Oilatum Junior Cream

1. Name Of The Medicinal Product

Oilatum Junior Cream

2. Qualitative And Quantitative Composition

Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.

Also contains cetostearyl alcohol and potassium sorbate.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Cream.

A white to off-white cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Oilatum Junior Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions.

4.2 Posology And Method Of Administration

Oilatum Junior Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss.

Oilatum Junior Cream is suitable for adults, children and the elderly.

4.3 Contraindications

Should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).

Hospital users should follow local procedures and policies for using topical products on in-patients.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restrictions on the use of Oilatum Junior Cream during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

May cause irritation in patients hypersensitive to any of the ingredients

4.9 Overdose

Accidental ingestion may cause nausea and vomiting. Administer copious quantities of water as required. Excessive topical application should cause no untoward effects other than greasy skin.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Light Liquid Paraffin and White Soft Paraffin exert an emollient effect by forming an occlusive film which reduces trans-epidermal water loss, thus helping to maintain normal skin humidity levels. Polyvinyl pyrrolidone enhances the strength and longevity of the occlusive film formed by the oil on the skin.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

White Soft Paraffin and Light Liquid Paraffin have been used in pharmaceutical and cosmetic preparations for many years. The formulation contains excipients that are commonly used in such preparations. The safety of these substances is well established by common use over long periods in man.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 1000 Monostearate

Cetostearyl alcohol

Glycerol

Potassium sorbate

Benzyl alcohol

Citric acid monohydrate

Povidone

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

Pack sizes 25g, 30g, 40g, 50g, 80g, 100g and150g: Three years

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100 and 1150ml: 30 Months

6.4 Special Precautions For Storage

Store below 25 ^○C

6.5 Nature And Contents Of Container

Internally lacquered, membrane sealed aluminium tube fitted with a polypropylene screw cap and packed into a carton. Pack size 40g and 80g.

Internally lacquered, membrane sealed aluminium tube fitted with a polyethylene screw cap and packed into a carton. Pack size 30g and 50g.

Laminate tubes with polypropylene caps packed into cartons. Pack sizes 100g and 150g.

And 25g, 50g and 150g in a high density polyethylene tube.

350ml and 500ml pump pack: high density polyethylene bottle fitted with a mechanical pump dispenser (polyethylene/ polypropylene components).

1000ml, 1050ml, 1100ml, 1150ml pump pack: polypropylene container and lid, fitted with a mechanical pump dispenser (polypropylene components), utilising a follower plate (HDPE).

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

Pack sizes 25g, 30g, 40g, 50g, 80g, 100g and 150g: PL 19494/0072

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100ml and 1150ml: PL 19494/0076

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation PL 19494/0072: 24^th January 2001/7 December 2010

Date of first authorisation PL19494/0076: 28^th October 2005

10. Date Of Revision Of The Text

PL 19494/0072: 19 August 2011

PL 19494/0076: 22 February 2011

Macrodantin Capsules 50mg B.P.

1. Name Of The Medicinal Product

Macrodantin Capsules 50mg

2. Qualitative And Quantitative Composition

Macrodantin capsules containing 50 mg Nitrofurantoin Ph Eur in macrocrystalline form.

3. Pharmaceutical Form

The 50 mg hard gelatin capsule has an opaque yellow cap and opaque white body marked 'Eaton 008'divided between the body and the cap.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.

Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.

Long term suppression: 50-100 mg once a day.

Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg day in four divided doses for seven days.

Suppressive - 1mg/kg, once a day.

For children under 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60 ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant due to immature erythrocyte enzyme systems.

Patients with known hypersensitivity to nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy which may become severe or irreversible has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis ) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary conditions of patients receiving long-term therapy is warranted (especially in the elderly).

Patient should be monitored closely for signs of hepatitis (particularly in long term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (if tested for reducing substances).

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast-feeding an infant known, or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely.

Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia and megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, and pruritus have occurred.

Lupus-like syndrome associated with pulmonary reaction to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever, and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur. However, these are limited to the genito-urinary tract because suppression of normal bacterial flora does not occur elsewhere in the body

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Macrodantin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin.

Most strains of proteus and serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

The nitrofurantoin macrocrystals of Macrodantin are specially formulated. The controlled crystal size is designed to control the speed of absorption and thus reduce the incidence of nausea. Clinical and animal studies indicate that Macrodantin therapy decreases the likelihood of nausea in patients who might experience these symptoms on Nitrofurantoin therapy. This special formulation of Nitrofurantoin had not caused any decrease in antibacterial efficacy.

Orally administered Macrodantin is readily absorbed in the upper gastrointestinal tract at a slower rate and to reduced extent when compared to microcrystalline Nitrofurantoin. Blood concentrations at therapeutic dosage are usually low with an elimination half-life of about 30 minutes or less

Maximum urinary excretion usually occurs 4-5 hours after administration of macrocrystalline Nitrofurantoin. Urinary drug dose recoveries of about 25-30% are obtained.

5.3 Preclinical Safety Data

Carcinogenic effect of nitrofurantoin in animal studies was observed. However, human data and extensive use of nitrofurantoin over 50 years do not support such observations.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The capsule fill contains lactose monohydrate, maize starch and purified talc. The capsule shell contains quinoline yellow (E104), titanium dioxide (E171), gelatin, sodium lauryl sulphate. The printing ink contains shellac and black iron oxide (E172).

6.2 Incompatibilities

Not known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Storage temperature must not exceed 30^oC.

6.5 Nature And Contents Of Container

Macrodantin 50 mg capsules are supplied in a PVC/aluminium foil blister pack of 30. Each pack comprises 3 blister cards containing 10 capsules on each card.

6.6 Special Precautions For Disposal And Other Handling

Macrodantin should be used as directed by physician.

A patient information leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0048

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000 / 24/05/2002

10. Date Of Revision Of The Text

13/08/2010

Mintuss DR Syrup

dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate

Dosage Form: syrup
MINTUSS™ DR

SYRUP

Rx Only

Mintuss DR Syrup Description

Mintuss™ DR Syrup is an alcohol-free, sugar-free red syrup with strawberry flavor.

Each teaspoonful (5 mL) contains:
Dextromethorphan hydrobromide	15 mg
Phenylephrine hydrochloride	6 mg
Chlorpheniramine maleate	2 mg

Antitussive/Nasal Decongestant/Antihistaminic syrup for oral administration.

Inactive ingredients

Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, D&C Red #33, FD&C Red #40, Strawberry Flavor and Purified Water.

Phenylephrine Hydrochloride is an orally effective nasal decongestant having the chemical name Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. Its structure is as follows:

C9H13NO2•HCl           203.67

Chlorpheniramine Maleate is an antihistaminic having the chemical name 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). Its structure is as follows:

C16H19CIN2•C4H4O4           390.86

Dextromethorphan Hydrobromide is an antitussive having the chemical name Morphinan, 3-methoxy-17-methyl-, (9α,13α,14α)-, hydrobromide, monohydrate. Its structure is as follows:

C18H25NO • HBr • H2O           370.32

Mintuss DR Syrup - Clinical Pharmacology

Dextromethorphan hydrobromide acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Phenylephrine hydrochloride is an α-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating α-receptors within the mucosa of the respiratory tract. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency.

Chlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Chlorpheniramine maleate is a member of the alkylamine class of antihistamines which are among the least sedating antihistamines.

INDICATIONS

Mintuss™ DR Syrup is indicated for the temporary relief of coughs and upper respiratory relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Hypersensitivity to any of the ingredients. Because of the drying effect on lower respiratory secretions, Mintuss™ DR Syrup is not recommended in the treatment of bronchial asthma. The product is also contraindicated in patients with severe hypertension, severe coronary artery disease, narrow-angle glaucoma, urinary retention, peptic ulcer, and in patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy).

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

Hypertensive crisis can occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued, and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling.

Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients. Do no exceed recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Precautions

General

Because of its antihistamine component, Mintuss™ DR Syrup should be used with caution in patients with a history of bronchial asthma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Mintuss™ DR Syrup should be used judiciously and sparingly in patients with hypertension, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Information for Patients

Antihistamines may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Patients should be cautioned accordingly.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA.)

Drug Interactions

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.) When such combined therapy is contemplated, the dose of one or both agents should be reduced. The use of phenylephrine with other sympathomimetic amines and MAO inhibitors (or for 14 days after stopping MAOI therapy) may produce an additive elevation of blood pressure. MAO inhibitors (or for 14 days after stopping MAOI therapy) may prolong the anticholinergic effects of antihistamines (See WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Mintuss™ DR Syrup to assess the carcinogenic and mutagenic potential, or the affect on fertility have not been performed.

Usage in Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Mintuss™ DR Syrup. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. It should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Mintuss ™ DR Syrup is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from this product, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Adverse Reactions

The most frequent adverse reactions to Mintuss™ DR Syrup include sedation, dryness of mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity,and pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias.

Central Nervous System: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

Gastrointestinal System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea or constipation.

Genitourinary System: Urinary frequency, difficult urination.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Symptoms of overdosage with phenylephrine include hypertension, headache, convulsions, cerebral hemorrhage, and vomiting. Effects of antihistamine overdosage may vary from central nervous system depression (sedation, apnea diminished mental alertness, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions) to death.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances, tracheotomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdosage of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Mintuss DR Syrup Dosage and Administration

Adults and children over 12 years

2 teaspoonfuls (10 mL) every 6 hours. Children 6 to 12 years: 1 teaspoonful (5mL) every 6 hours. Do not exceed 4 doses during a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Mintuss DR Syrup Supplied

Mintuss ™ DR Syrup is an alcohol-free, sugar-free red syrup with a strawberry flavor supplied in bottles of 16 fl oz, NDC 51991-286-16.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F). See USP Controlled Room Temperature. Protect from freezing.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

ISS. 11/02

Rev. 4/08

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-286-16

Mintuss™ DR

Syrup

ACTIVE INGREDIENTS:
Each teaspoonful (5 mL) contains:
Dextromethorphan HBr	15 mg
Phenylephrine HCl	6 mg
Chlorpheniramine Maleate	2 mg

INACTIVE INGREDIENTS: Sodium

Benzoate, Citric Acid, Sorbitol Solution,

Glycerin, D&C Red #33, FD&C Red #40,

Strawberry Flavor and Purified Water.

• Sugar Free


• Alcohol Free

Rx Only

Net Contents:

16 fl oz (One Pint) 473 mL

MINTUSS DR  dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-286 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 6 mg  in 5 mL Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Sodium Benzoate   Citric Acid Monohydrate   Sorbitol   Glycerin   D&C Red No. 33   FD&C Red No. 40   Water

Product Characteristics Color RED Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-286-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/01/2002	09/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Trimed		182050567	MANUFACTURE

Revised: 10/2010Breckenridge Pharmaceutical, Inc.

More Mintuss DR Syrup resources

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• Mintuss DR Syrup Dosage
• Mintuss DR Syrup Use in Pregnancy & Breastfeeding
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• Cough and Nasal Congestion

Cubicin

Pronunciation: DAP-toe-MYE-sin
Generic Name: Daptomycin
Brand Name: Cubicin

Cubicin is used for:

Treating serious infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cubicin is an antibiotic. It works by killing sensitive bacteria.

Do NOT use Cubicin if:

• you are allergic to any ingredient in Cubicin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cubicin:

Some medical conditions may interact with Cubicin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have muscle problems, nerve problems, liver problems, kidney problems, or bowel problems caused by antibiotic use

Some MEDICINES MAY INTERACT with Cubicin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• HMG-CoA reductase inhibitors (eg, atorvastatin) or warfarin because the risk of their side effects may be increased by Cubicin


• Tobramycin because its effectiveness may be decreased by Cubicin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cubicin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cubicin:

Use Cubicin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cubicin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Cubicin at home, a health care provider will teach you how to use it. Be sure you understand how to use Cubicin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Cubicin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• To clear up your infection completely, use Cubicin for the full course of treatment. Keep using it even if you feel better in a few days.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Cubicin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cubicin.

Important safety information:

• Cubicin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Cubicin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Cubicin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Be sure to use Cubicin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Cubicin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Eosinophilic pneumonia, a rare but serious condition, has been reported with the use of Cubicin. Contact your doctor right away if you experience new or worsening fever, cough, shortness of breath, or trouble breathing. Discuss any questions or concerns with your doctor.


• Lab tests, including white blood cell counts and creatine phosphokinase, may be performed while you use Cubicin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cubicin with caution in the ELDERLY; they may be more sensitive to its effects.


• Cubicin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cubicin while you are pregnant. It is not known if Cubicin is found in breast milk. If you are or will be breast-feeding while you use Cubicin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cubicin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache; nausea; pain, swelling, or redness at the injection site; sore throat; sweating; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; chest pain; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or watery stools; change in the amount of urine produced; fever; muscle pain or weakness; numbness or tingling; severe or persistent diarrhea; stomach cramps/pain; swelling (eg, of the hands, ankles, feet); symptoms of eosinophilic pneumonia (eg, new or worsening fever, cough, shortness of breath, or trouble breathing); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cubicin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cubicin:

Cubicin is usually handled and stored by a health care provider. If you are using Cubicin at home, store Cubicin as directed by your pharmacist or health care provider. Keep Cubicin out of the reach of children and away from pets.

General information:

• If you have any questions about Cubicin, please talk with your doctor, pharmacist, or other health care provider.


• Cubicin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cubicin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cubicin resources

• Cubicin Side Effects (in more detail)
• Cubicin Use in Pregnancy & Breastfeeding
• Cubicin Drug Interactions
• Cubicin Support Group
• 0 Reviews for Cubicin - Add your own review/rating

• Cubicin Prescribing Information (FDA)


• Cubicin Consumer Overview


• Cubicin Monograph (AHFS DI)


• Cubicin Advanced Consumer (Micromedex) - Includes Dosage Information


• Daptomycin Professional Patient Advice (Wolters Kluwer)

Compare Cubicin with other medications

• Bacteremia
• Endocarditis
• Methicillin-Resistant Staphylococcus Aureus Infection
• Skin and Structure Infection
• Skin Infection

Ranitidine 150mg / 10ml Oral Solution

Ranitidine 150mg/10ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
  
  If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What Ranitidine Oral Solution is and what it is used for


• 2. Before you take Ranitidine Oral Solution


• 3. How to take Ranitidine Oral Solution


• 4. Possible side effects


• 5. How to store Ranitidine Oral Solution


• 6. Further information

What Ranitidine Oral Solution is and what it is used for

Ranitidine belongs to a group of medicines called H₂ antagonists, which reduce the amount of acid in your stomach.

For adults, this medicine is used to:

• Heal and stop ulcers in the stomach, or the part of the gut it empties into (the duodenum)


• Heal and stop problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach.
  
  This can cause pain or discomfort known as indigestion or heartburn


• Prevent ulcers from bleeding


• Prevent ulcers which may be caused by medicines called Non-Steroidal Anti-Inflammatories (NSAIDs), often used to treat arthritis


• Be given before an operation to prevent acid coming up from the stomach whilst under anaesthetic.

For children (3 to 18 years), this medicine is used to:

• Heal ulcers in the stomach, or the part of the gut it empties into (the duodenum)


• Heal and stop problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach.
  
  This can cause pain or discomfort known as indigestion or heartburn.

Before you take Ranitidine Oral Solution

Do not take this medicine and speak to your doctor if you have ever had an allergic reaction to:

• ranitidine


• anything else in this liquid (listed in Further Information on the back page).

An allergic reaction can include a rash, itching or shortness of breath.

Do not take this medicine if you are pregnant or likely to become pregnant soon and if you are breast-feeding.

Take special care with this medicine. Talk to your doctor before taking if:

• you have kidney problems


• you have a rare illness called porphyria


• you have lost weight recently and also have stomach ache, stomach pain or indigestion at the same time


• you are over 40 and recently had stomach ache, stomach pain or indigestion for the first time or which has recently changed.

You should see your doctor regularly especially if you are taking Ranitidine syrup as well as medicine for arthritis. This is particularly important in the elderly or those with a history of ulcers.

Taking other medicines

Tell your doctor if you are taking any of these medicines:

• Non-steroidal anti-inflammatories (NSAIDs) e.g. indometacin, aspirin


• glipizide or glibenclamide (diabetes medicine)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and Breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor before taking this medicine.

Driving and using machines

The amount of alcohol in this medicine (8%w/v) may affect your ability to drive or use machines.

Important information about some of the ingredients of this medicine:

This medicine contains:

• Ethanol (alcohol) - each 5ml spoonful contains 8% w/v ethanol which is equal to 11ml of beer or 5ml of wine. Speak to the doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.



• This medicine contains sorbitol, a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.



• This medicinal product contains 11mg of sodium per 5ml dose. It is to be taken into consideration by patients on a controlled sodium diet.

How to take Ranitidine 150mg/10ml Oral Solution

• Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure


• Ranitidine Oral Solution contains 75mg of ranitidine (as hydrochloride) in one 5ml spoonful


• Take this medicine by mouth only.

Adults and children aged 12 years and above

For stomach or duodenal ulcers, adults usually take 150mg (two 5ml spoonsful) twice a day in the morning and evening or 300mg (four 5ml spoonsful) at bedtime for 4 weeks.

The doctor may change the dose.

There are rare diseases in which the acid production is very excessive and these are usually treated with a dose of 600mg to 900mg (40 to 60ml) or even higher.

It is important that you keep taking the medicine until you finish the full course of treatment prescribed.

Even when you feel better, your doctor may decide to continue your treatment with Ranitidine Oral Solution in order to prevent the pain and discomfort returning. Depending on the disease you are being treated for, the usual dosage may be 150mg (two 5ml spoonsful) or 300mg (four 5ml spoonsful) once daily or 150mg (two 5ml spoonsful) twice daily.

Children (3 to 11 years)

Your doctor will work out the right dose in mls based on your child's weight. Make sure you follow the instructions on the label.

Treatment of stomach and duodenal ulcers:

The usual dose is 2mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks.

Treatment of heartburn due to too much acid:

The usual dose is 2.5mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5mg for each kg, twice a day. Take each dose about 12 hours apart.

Please note that this medicine contains alcohol. See Section 2, Important information about some of the ingredients of this medicine for more details.

If you take more ranitidine than you should (overdose):

Taking more than it says on the label is unlikely to be dangerous, unless a lot of syrup is taken at once. In that case, phone your doctor or go to your nearest accident and emergency department straight away.

If you forget to take this medicine:

Take another dose as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, ranitidine can cause side effects, although not everybody gets them. The side effects below may sometimes happen.

If you have an allergic reaction to this medicine see a doctor immediately.

An allergic reaction may include:

• any kind of skin rash or "hives", flaking skin, boils or sore lips, swelling (of the face, eyelids, lips, mouth or tongue), fever


• sudden wheezing, fluttering or tightness of the chest, chest pain, feeling faint especially when standing up
  or collapse.

If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:

• feeling sick, loss of appetite with or without jaundice (yellow colour of skin and white of eyes) as this may be due to hepatitis (inflammation/infection of the liver)


• unusual tiredness, shortness of breath, bruising more easily or other signs of infection – this could be a sign of blood problems


• slow or irregular heartbeats


• severe stomach pain rarely caused by an inflamed pancreas or a change in the type of stomach pain


• skin rash - occasionally severe (red spots/purple spots or rash) or itching


• feeling confused


• hallucinations (seeing, feeling or hearing things that are not there)


• feelings of depression


• inflamed blood vessels (vasculitis)


• blurred vision


• diarrhoea or constipation


• kidney problems (symptoms may include a change in the amount of urine passed and its colour, nausea, vomiting, confusion, fever and rash)


• recurring infections


• fainting.

Tell your doctor if you get any of these side effects:

• headache or dizziness


• tiredness


• pains in muscles or joints


• uncontrolled movements. This usually stops once you stop taking this medicine


• hair loss


• if you are a man, breast tenderness, breast enlargement or sexual impotence. This sexual impotence usually gets better once you stop taking this medicine.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell
your doctor or pharmacist.

If you have taken all the medicine and still feel unwell, or if you have not taken all the medicine but feel worse, tell your doctor.

Tell your doctor that you are taking ranitidine if you have a blood, urine or other test carried out as the medicine may affect the result.

How to store Ranitidine 150mg/10ml Oral Solution

• Keep out of the reach and sight of children


• Do not store above 25°C


• Do not use 1 month from the date you first open it


• Do not use after the expiry date (month, year) on the label and carton


• The expiry date refers to the last day of that month


• If it is out of date or you no longer want it, take it back to the pharmacy


• Do not use Ranitidine Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Ranitidine 150mg/10ml Oral Solution contains

The active substance is Ranitidine Hydrochloride.

The other ingredients are disodium hydrogen phosphate, sodium dihydrogen phosphate, saccharin sodium, sorbitol solution, ethanol (alcohol) 8%w/v, garden mint flavour and purified water. Total sodium content 11mg/5ml.

What Ranitidine 150mg/10ml Oral Solution looks like and contents of the pack

Ranitidine 150mg/10ml Oral Solution is a white to pale yellow liquid which smells of mint.

It comes in a brown glass bottle holding either 100ml or 300ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

Tel: +44 (0)113 244 1400

This leaflet was last approved in November 2009.

P0485

Aquachloral Supprettes

Generic Name: chloral hydrate rectal (klor al HYE drate)

Brand Names: Aquachloral Supprettes

What is Aquachloral Supprettes (chloral hydrate rectal)?

Chloral hydrate is a hypnotic and a sedative medication that slows the activity of your central nervous system.

Chloral hydrate rectal is used to treat sleep problems (insomnia). It is sometimes given before a surgery to help you relax.

Chloral hydrate rectal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aquachloral Supprettes (chloral hydrate rectal)?

Do not take chloral hydrate rectal by mouth. It is for use only in your rectum. Do not use this medication if you have severe kidney or liver disease, or if you are allergic to chloral hydrate or aspirin. Tell your doctor if you have any type of kidney, heart, or liver disease, or if you are allergic to aspirin. You may not be able to use chloral hydrate rectal, or you may need a dosage adjustment or special tests during treatment.

Try to empty your bowel and bladder just before using the chloral hydrate rectal suppository. To treat insomnia, use this medicine only at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

What should I discuss with my health care provider before using Aquachloral Supprettes (chloral hydrate rectal)?

Do not use this medication if you have severe kidney or liver disease, or if you are allergic to chloral hydrate or aspirin.

Before using chloral hydrate rectal, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease or heart rhythm problems;

  
  


• 
  

  ulcer, colitis, or other stomach disorders;

  
  


• 
  

  adenoids, sleep apnea, or other breathing disorders;

  
  


• 
  

  porphyria;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  thoughts of suicide; or

  
  


• 
  

  a history of drug abuse or dependence.

  
  

If you have any of these conditions, you may not be able to use chloral hydrate rectal, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chloral hydrate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medication may be habit-forming. You may have severe or life-threatening withdrawal symptoms when you stop using chloral hydrate rectal after using it for 2 weeks or longer. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Older adults may be more sensitive to the sedative effects of chloral hydrate rectal.

How should I use Aquachloral Supprettes (chloral hydrate rectal)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Chloral hydrate rectal should be used only for a short time, such as 2 to 7 days in a row, unless your doctor tells you otherwise.

Do not take chloral hydrate rectal by mouth. It is for use only in your rectum.

Try to empty your bowel and bladder just before using the chloral hydrate rectal suppository. To treat insomnia, use this medicine only at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. Wet the tip of the suppository with water to make it easier to insert. Do not use petroleum jelly (Vaseline).

For best results from the suppository, lie down on your left side with your right knee bent toward your chest. Gently insert the suppository and remain lying down for a minute or two. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom during this time.

Wash your hands after you are finished using the suppository.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using chloral hydrate rectal.

Do not stop using chloral hydrate rectal without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Try to use the medicine only at a time when you can lie down or sleep afterward. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a chloral hydrate rectal overdose may include extreme drowsiness, nausea, shallow breathing, fainting, uneven heartbeats, cold feeling, muscle weakness, or jaundice (yellowing of the skin or eyes).

What should I avoid while using Aquachloral Supprettes (chloral hydrate rectal)?

Avoid drinking alcohol, which can increase some of the side effects of chloral hydrate rectal.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chloral hydrate rectal.

Chloral hydrate rectal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Aquachloral Supprettes (chloral hydrate rectal) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  uneven heartbeats;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  shallow breathing;

  
  


• 
  

  weakness, lack of coordination; or

  
  


• 
  

  a red, blistering, peeling skin rash.

  
  

Less serious side effects may be more likely to occur, such as:

• 
  

  drowsiness, deep sleep;

  
  


• 
  

  headache, or hangover feeling;

  
  


• 
  

  nausea, vomiting, indigestion, gas, stomach pain;

  
  


• 
  

  redness or drooping of your eyelids;

  
  


• 
  

  excitement or confusion; or

  
  


• 
  

  mild itching or skin rash.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aquachloral Supprettes (chloral hydrate rectal)?

Before using chloral hydrate rectal, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin). You may not be able to use chloral hydrate rectal, or you may need dosage adjustments or special tests during treatment.

There may be other drugs that can affect chloral hydrate rectal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Aquachloral Supprettes resources

• Aquachloral Supprettes Side Effects (in more detail)
• Aquachloral Supprettes Use in Pregnancy & Breastfeeding
• Aquachloral Supprettes Drug Interactions
• Aquachloral Supprettes Support Group
• 1 Review for Aquachloral Supprettes - Add your own review/rating

• Aquachloral Supprettes Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Aquachloral Supprettes Advanced Consumer (Micromedex) - Includes Dosage Information


• Chloral Hydrate Professional Patient Advice (Wolters Kluwer)


• Chloral Hydrate Monograph (AHFS DI)


• Chloral Hydrate MedFacts Consumer Leaflet (Wolters Kluwer)


• Somnote Prescribing Information (FDA)

Compare Aquachloral Supprettes with other medications

• Insomnia
• Sedation

Where can I get more information?

• Your pharmacist has information about chloral hydrate rectal written for health professionals that you may read.

See also: Aquachloral Supprettes side effects (in more detail)

Umecta Suspension

Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Umecta

Umecta Suspension is used for:

Promoting the healing of certain conditions of the fingernails and toenails (eg, hyperkeratotic conditions). It may also be used to treat certain other skin conditions (eg, corns; calluses; rough, dry skin) as determined by your doctor.

Umecta Suspension is a debriding agent. It works by helping to break down dead skin and pus, which helps to soften, loosen, and shed hard, scaly skin and nails.

Do NOT use Umecta Suspension if:

• you are allergic to any ingredient in Umecta Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Umecta Suspension:

Some medical conditions may interact with Umecta Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Umecta Suspension. Because little, if any, of Umecta Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Umecta Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Umecta Suspension:

Use Umecta Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and after using Umecta Suspension unless your hands are part of the treated area.


• Shake well before each use.


• To use Umecta Suspension on the skin, apply a small amount of Umecta Suspension to the affected area as directed by your doctor. Rub it in completely until it is absorbed. If you get Umecta Suspension on any skin that is not part of the treated area, wash it off thoroughly.


• To use Umecta Suspension on the nail, apply a small amount of Umecta Suspension on the affected area as directed by your doctor. If you get Umecta Suspension on any skin that is not part of the treated area, wash it off thoroughly.


• You may cover the affected area unless directed otherwise by your doctor.


• Use Umecta Suspension on a regular schedule to get the most benefit from it.


• If you miss a dose of Umecta Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Umecta Suspension.

Important safety information:

• Umecta Suspension is for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get it in any of these areas, rinse right away with cool water.


• Do not exceed the recommended dose, use for longer than prescribed, or use for other skin conditions without checking with your doctor.


• If your symptoms do not get better or if they get worse, check with your doctor.


• Do not apply to broken or severely irritated skin.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Umecta Suspension while you are pregnant. It is not known if Umecta Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Umecta Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Umecta Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild skin irritation; temporary burning, stinging, or itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; severe or persistent burning or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Umecta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Umecta Suspension may be harmful if swallowed.

Proper storage of Umecta Suspension:

Store Umecta Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Umecta Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Umecta Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Umecta Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Umecta Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Umecta resources

• Umecta Side Effects (in more detail)
• Umecta Use in Pregnancy & Breastfeeding
• Umecta Support Group
• 0 Reviews for Umecta - Add your own review/rating

Compare Umecta with other medications

• Dermatological Disorders
• Dry Skin
• Pityriasis rubra pilaris

Aranesp

Generic Name: darbepoetin alfa (Injection route)

dar-be-POE-e-tin AL-fa

Injection route(Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events. In patients with chronic kidney disease (CKD), patients are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL or higher in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. Therefore, in CKD patients, use at the lowest sufficient dose is recommended. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. In patients with cancer, use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program (www.esa-apprise.com or 1-866-284-8089) to prescribe and/or dispense darbepoetin alfa to patients with cancer. Patients receiving myelosuppressive therapy should not be treated with ESAs when the anticipated outcome is cure .

Commonly used brand name(s)

In the U.S.

• Aranesp

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Erythropoietic

Uses For Aranesp

Darbepoetin alfa injection causes the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Darbepoetin may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving chemotherapy to treat cancer. Darbepoetin alfa is used to treat severe anemia in these patients.

This medicine is available only with your doctor's prescription.

Before Using Aranesp

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darbepoetin alfa injection in children with chronic kidney failure who are 1 year of age and older. Safety and efficacy have not been established in children with chronic kidney failure who are younger than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of darbepoetin alfa injection in children with cancer. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darbepoetin alfa injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Thalidomide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aluminum poisoning, severe or


• Bleeding, severe or


• Bone marrow fibrosis (osteofibrosis cystica) or


• Folic acid deficiency or


• Infections, inflammation, or cancer or


• Iron deficiency or


• Vitamin B12 deficiency—May cause a delay in response to treatment.

• Blood clots (history of) or other problems with the blood or


• Congestive heart failure or


• Heart attack, history of or


• Heart bypass surgery or


• Heart or blood vessel disease or


• Stroke, history of or


• Thrombosis, at risk for—The chance of side effects may be increased.

• Bone marrow problems (e.g., hemolytic anemia, sickle cell anemia, porphyria, thalassemia)—Use of darbepoetin alfa injection has not been established in patients with these conditions.

• Hypertension (high blood pressure), uncontrolled or


• Pure red cell aplasia (rare bone marrow disease)—Should not be used in patients with these conditions.

• Seizures, history of—May make this condition worse.

Proper Use of Aranesp

For cancer patients: It is very important that you understand and become familiar with the Aranesp® Medication Guide. You may also be asked to sign the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) acknowledgement form. Direct any questions to your doctor or pharmacist before starting darbepoetin alfa therapy.

This medicine comes with a patient instructions insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Darbepoetin alfa is usually given by a doctor. However, medicines given by injection are sometimes used at home. If you will be using darbepoetin alfa at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine is available in 3 forms. You may use a vial, a prefilled syringe with an UltraSafe® Needle Guard, or a prefilled SureClick™ autoinjector.

If you need a full dose of this medicine, use the prefilled SureClick™ autoinjector unless your doctor tells you otherwise.

This medicine may be given as a shot under your skin or into a vein. If your doctor tells you to inject it a certain way, follow your doctor's instructions.

If you are giving this medicine at home:

• Use a new needle and syringe each time you inject your medicine.


• Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given.


• Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Do not shake the container of medicine before you use it, and do not use this medicine if it has been frozen.

You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Carefully follow your doctor's instructions about any special diet. You may need to eat foods that contain iron, folic acid, or vitamin B12 such as eggs, certain cereals, meats, and vegetables, or you may take an iron, folic acid, or vitamin B12 supplement while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For anemia from chronic kidney failure:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.45 to 0.75 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once a week or once every 2 weeks. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For anemia from cancer chemotherapy:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 2.25 micrograms (mcg) per kilogram (kg) of body weight once a week or 500 mcg once every 3 weeks injected under the skin. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from bright light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using Aranesp

People with severe anemia usually feel very tired and sick. When darbepoetin alfa begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. But darbepoetin alfa only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention. Even if you are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments.

It is very important that your doctor check your blood regularly while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

Darbepoetin alfa may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before major surgery. If you have chest pain; shortness of breath; or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the cancer in some patients. If you are concerned about this, talk with your doctor.

Darbepoetin alfa sometimes causes convulsions (seizures), especially during the first few months of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause a serious injury if a seizure occurs while you are performing them.

One form of darbepoetin alfa injection has an ingredient that comes from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by darbepoetin alfa treatment) may need to be on a special diet or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.

In addition to darbepoetin alfa, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Darbepoetin alfa will not work well if you do not have enough iron or vitamins in your body.

Aranesp Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• accumulation of pus


• arm, back, or jaw pain


• blurred vision


• breathing problems (irregular, noisy, or trouble when resting)


• chest pain, discomfort, tightness, or heaviness


• chills


• confusion


• cough producing mucus


• decrease in the amount of urine


• diarrhea


• dilated neck veins


• dizziness, fainting, or lightheadedness


• dry mouth


• fast, slow, or irregular heartbeat


• fatigue or tiredness (extreme or unusual)


• fever


• headache


• nausea


• pain, tenderness, swelling, or warmth over injection site


• pounding in the ears


• rapid breathing


• rapid or pounding pulse


• shortness of breath


• skin discoloration at the injection site


• sunken eyes


• sweating


• swelling of the ankles, face, fingers, feet, hands, or lower legs


• thirst


• trouble with breathing


• unconsciousness


• vomiting


• weight gain


• wheezing


• wrinkled skin

Less common

• Anxiety


• convulsions


• difficulty with speaking (slow speech or unable to speak)


• double vision


• trouble with thinking


• trouble with walking


• unable to move the arms, legs, or face muscles (including numbness and tingling)

Rare

• Fever and sore throat


• hives


• itching


• pale skin


• skin rash


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation


• general feeling of discomfort or illness


• lack or loss of strength


• loss of appetite


• muscle aches, pains, or stiffness


• pain in the joints


• runny nose


• shivering


• sneezing


• trouble with sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Aranesp side effects (in more detail)

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More Aranesp resources

• Aranesp Side Effects (in more detail)
• Aranesp Use in Pregnancy & Breastfeeding
• Aranesp Drug Interactions
• Aranesp Support Group
• 1 Review for Aranesp - Add your own review/rating

• Aranesp Prescribing Information (FDA)


• Aranesp Consumer Overview


• Aranesp Monograph (AHFS DI)


• Aranesp MedFacts Consumer Leaflet (Wolters Kluwer)


• Darbepoetin Alfa Professional Patient Advice (Wolters Kluwer)

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