Topotecan

Pronunciation: TOE-poe-TEE-kan
Generic Name: Topotecan
Brand Name: Hycamtin

Topotecan may cause severe and sometimes fatal bone marrow suppression and blood problems. These blood problems may increase the risk of developing a severe infection. Topotecan should not be used in patients who have low platelet levels or very low white blood cell levels. Contact your doctor at once if you have symptoms of an infection (eg, fever, chills, persistent sore throat, painful urination), unusual bruising or bleeding, or unusual fatigue. Frequent blood tests will be performed to monitor for side effects. Be sure to keep all doctor and lab appointments.

Topotecan is used for:

Treating certain types of ovarian or lung cancer that do not respond well to other types of cancer treatment. It may be used to treat certain types of cervical cancer that cannot be treated by surgery or radiation therapy. It may also be used for other conditions as determined by your doctor.

Topotecan is an antineoplastic. It works by killing certain cancer cells.

Do NOT use Topotecan if:

• you are allergic to any ingredient in Topotecan


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


• you have severe bone marrow problems, low platelets, or very low white blood cell levels

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

Before using Topotecan:

Some medical conditions may interact with Topotecan. 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 a history of kidney problems, bone marrow problems, or blood problems


• if you have a history of lung problems (eg, interstitial lung disease [ILD], pulmonary fibrosis, lung cancer) or if your chest area has been exposed to radiation.


• if you have recently received a live vaccine

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

• Medicines that may harm the lungs (eg, certain antiarrhythmics, certain antibiotics, amphotericin B, certain cancer drugs) because the risk of serious lung problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the lungs


• Carboplatin, cisplatin, granulocyte colony-stimulating factor (G-CSF), or other antineoplastic medicines because the risk or duration of severe bone marrow or blood problems may be increased


• Hydantoins (eg, phenytoin) because they may decrease Topotecan's effectiveness


• Live vaccines (eg, measles, mumps) because the risk of their side effects may be increased by Topotecan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Topotecan 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 Topotecan:

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

• Topotecan is usually given as an injection at your doctor's office, hospital, or clinic.


• If Topotecan accidentally spills on your skin, wash it off immediately with soap and water.


• If you miss a dose of Topotecan, contact your doctor right away.

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

Important safety information:

• Topotecan may cause tiredness or weakness during treatment and for several days after treatment. These effects may be worse if you take it with alcohol or certain medicines. Use Topotecan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Topotecan may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Topotecan may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Some patients taking Topotecan have developed severe and sometimes fatal lung problems. The risk may be greater if you have a history of certain lung problems or if your chest area has been exposed to radiation. It may also be greater if you take certain other medicines. Tell your doctor right away if you develop a cough, fever, shortness of breath, blue or unusually pale skin or nails, or chest pain.


• If nausea, vomiting, diarrhea, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Topotecan. Talk with your doctor before you receive any vaccine.


• If you may become pregnant, you must use an effective form of birth control while you take Topotecan. If you have questions about effective birth control, talk with your doctor.


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


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


• Topotecan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Topotecan if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Topotecan is found in breast milk. Do not breast-feed while taking Topotecan.

Possible side effects of Topotecan:

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; fatigue; hair loss; loss of appetite; nausea; stomach pain; tiredness; vomiting; weakness.

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); blue or unusually pale skin or nails; fever, chills, or persistent sore throat; painful or burning urination; persistent or severe cough; persistent or severe pain, redness, or swelling at the injection site; persistent or severe stomach pain or cramps; persistent or severe tiredness or weakness; shortness of breath; unusual or unexplained bruising or bleeding; yellowing of the eyes or skin.

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: Topotecan 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 Topotecan:

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

General information:

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


• Topotecan 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 Topotecan. 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 Topotecan resources

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

• Topotecan Prescribing Information (FDA)


• topotecan Advanced Consumer (Micromedex) - Includes Dosage Information


• topotecan Concise Consumer Information (Cerner Multum)


• Hycamtin Monograph (AHFS DI)


• Hycamtin Prescribing Information (FDA)

Compare Topotecan with other medications

• Cancer
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Daktarin Oral Gel

1. Name Of The Medicinal Product

DAKTARIN™ Oral Gel

2. Qualitative And Quantitative Composition

Each gram of Daktarin Oral Gel contains 20 mg of miconazole.

For excipients, see 6.1.

3. Pharmaceutical Form

Oral gel.

White gel with orange taste.

4. Clinical Particulars

4.1 Therapeutic Indications

Oral treatment and prevention of fungal infections of the oropharynx and gastrointestinal tract, and of super infections due to Gram-positive bacteria.

4.2 Posology And Method Of Administration

For oral administration.

Dosage is based on 15 mg/kg/day (0.625 ml/kg/day).

Adults:

1-2 spoonfuls (5-10 ml) of gel four times per day.

Elderly:

As for adults.

Children aged 6 years and over:

One spoonful (5 ml) of gel four times per day.

Children aged 2-6 years:

One spoonful (5 ml) of gel twice per day.

Infants 4 months- 2 years:

Half a spoonful (2.5 ml) of gel twice per day. Each dose should be divided into smaller portions (see section 4.4)

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

For localised lesions of the mouth, a small amount of gel may be applied directly to the affected area with a clean finger.

For topical treatment of the oropharynx, the gel should be kept in the mouth for as long as possible.

Treatment should be continued for up to 2 days after the symptoms have cleared.

For oral candidosis, dental prostheses should be removed at night and brushed with the gel.

4.3 Contraindications

Known hypersensitivity to miconazole or to any of the excipients.

In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.

In patients with liver dysfunction.

Coadministration of the following drugs that are subject to metabolism by CYP3A4: (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction)

- Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine

- Ergot alkaloids

- HMG-CoA reductase inhibitors such as simvastatin and lovastatin

- Triazolam and oral midazolam

4.4 Special Warnings And Precautions For Use

If the concomitant use of Daktarin and anticoagulants is envisaged, the anti-coagulant effect should be carefully monitored and titrated. (see section 4.5)

It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly.

In patients using certain oral hypoglycaemics such as sulphonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with miconazole and appropriate measures should be considered (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction).

Particularly in infants and young children, caution is required to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat and each dose should be divided into smaller portions. Observe the patient for possible choking.

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.:

Oral miconazole is contraindicated with the coadministration of the following drugs that are subject to metabolism by CYP3A4 (See Section 4.3 Contraindications);

- Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine

- Ergot alkaloids

- HMG-CoA reductase inhibitors such as simvastatin and lovastatin

- Triazolam and oral midazolam

When coadministered with oral miconazole the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse events. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:

Drugs subject to metabolism by CYP2C9 (see Section 4.4 Special Warnings and Precautions for Use);

- Oral anticoagulants such as warfarin

- Oral hypoglycaemics such as sulphonylureas

- Phenytoin

Other drugs subject to metabolism by CYP3A4;

- HIV Protease Inhibitors such as saquinavir;

- Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel;

- Certain calcium channel blockers such as dihydropyridines and verapamil;

- Certain immunosuppressive agents: cyclosporin, tacrolimus, sirolimus (= rapamycin)

- Others: , carbamazepine, cilostazol, disopyramide, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

4.6 Pregnancy And Lactation

In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Daktarin Oral Gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits.

It is not known whether miconazole is excreted in human milk. Caution should be exercised when prescribing Daktarin Oral Gel to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Daktarin should not affect alertness or driving ability.

4.8 Undesirable Effects

The safety of Daktarin Oral Gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or oral mycoses who participated in 1 randomised, active

Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most commonly reported (

Table A includes all identified ADRs, including those that that have been reported from post-marketing experience.

The frequency categories use the following convention: very common (

Adult Patients

Based on the pooled safety data from the 4 clinical trials in adults, common ADRs reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).

Paediatric Patients

In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very common, and regurgitation (8.7%) was common. As identified through post-marketing experience, choking may occur in infants and young children (See Section 4.3 Contraindications and Section 4.4 Special Warnings and Special Precautions). The frequency, type, and severity of other ADRs in children are expected to be similar to that in adults.

Table A: Adverse Drug Reactions in Patients Treated with DAKTARIN Oral Gel or Tablets

System Organ Class	Adverse Drug Reactions
Frequency Category
Common (	Uncommon (	Not Known
Immune System Disorders			Anaphylactic reaction, Angioedema, Hypersensitivity
Nervous System Disorders		Dysgeusia
Respiratory, Thoracic and Mediastinal Disorders			Choking
Gastrointestinal Disorders	Dry mouth, Nausea, Oral discomfort, Vomiting, Regurgitation		Diarrhoea, Stomatitis, Tongue discolouration
Hepatobiliary Disorders			Hepatitis
Skin and Subcutaneous Tissue Disorders			Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash
General Disorders and Administration Site Conditions	Product taste abnormal

4.9 Overdose

Symptoms:

In the event of accidental overdose, vomiting and diarrhoea may occur.

Treatment:

Treatment is symptomatic and supportive. A specific antidote is not available.

In the event of accidental ingestion of large quantities of Daktarin an appropriate method of gastic emptying may be used, if considered necessary (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction.)

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: A01A B09 and A07A C01

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci.

Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

5.2 Pharmacokinetic Properties

Absorption:

Miconazole is systemically absorbed after administration as the oral gel. Administration of a 60 mg dose of miconazole as the oral gel results in peak plasma concentrations of 31 to 49 ng/mL, occurring approximately two hours post-dose.

Distribution:

Absorbed miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%).

Metabolism and Elimination:

The absorbed portion of miconazole is largely metabolized; less than 1% of an administered dose is excreted unchanged in the urine. The terminal half-life of plasma miconazole is 20 to 25 hours in most patients. The elimination half-life of miconazole is similar in renally impaired patients. Plasma concentrations of miconazole are moderately reduced (approximately 50%) during hemodialysis. About 50% of an oral dose may be excreted in the faeces partly metabolized and partly unchanged.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Pregelatinised potato starch

Alcohol

Polysorbate 20

Sodium saccharin

Cocoa flavour

Orange flavour

Glycerol

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not Store above 30°C.

6.5 Nature And Contents Of Container

Aluminium tubes containing 5 g*, 15 g*, 30 g* 40 *g or 80 g gel.

A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided.

* not marketed

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 0242/0048

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 19 July 1977

Date of Renewal of Authorisation: 22 May 2008

10. Date Of Revision Of The Text

15 September 2010

Tenex

Generic Name: Guanfacine
Class: Central alpha-Agonists
VA Class: CV490
Chemical Name: N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride
Molecular Formula: C₉H₉Cl₂N₃O
CAS Number: 29110-47-2

Introduction

Phenylacetyl-guanidine derivative hypotensive agent; selective α₂-adrenergic agonist.^{1 2}

Uses for Tenex

Hypertension

Used alone or in combination with other classes of antihypertensive agents in the management of hypertension.^{1 3 4 5 6 8}

Thiazide diuretics are considered the preferred initial monotherapy for uncomplicated hypertension by JNC 7.^{6 7 8}

Hypotensive efficacy shown to be similar to that of clonidine and methyldopa.^{2 3 4}

Has been used in conjunction with diuretics (e.g., thiazides), producing a greater reduction in BP than is obtained with either drug alone.^{1 5 16}

Use of a diuretic or other antihypertensive agents may aid in overcoming tolerance to guanfacine and permit reduction of guanfacine dosage.²

Attention Deficit Hyperactivity Disorder

Has been used for the treatment of attention deficit hyperactivity disorder† (ADHD) in pediatric patients.^{9 10}

Produces a moderate reduction in symptoms of ADHD†; stimulants (e.g., methylphenidate, amphetamines) remain the drugs of choice for the management of ADHD because of their greater efficacy compared with that of other drugs (e.g., guanfacine).⁹

May be especially useful in pediatric patients with comorbid tic disorders, which can be triggered or worsened by stimulant therapy.⁹

Tenex Dosage and Administration

General

Hypertension

• 
  

  Adjust dosage carefully according to patient’s BP response and tolerance.^{1 2}

  
  


• 
  

  Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.⁶

  
  


• 
  

  Avoid large or abrupt reductions in BP.¹¹

  
  


• 
  

  Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients [stage 2 hypertension, comorbid conditions]) if BP control is inadequate at a given dosage; it may take months to control hypertension adequately while avoiding adverse effects of therapy.^{6 11}

  
  


• 
  

  SBP is the principal clinical end point, especially in middle-aged and geriatric patients.^{6 12 13} Once the goal SBP is attained, the goal DBP usually is achieved.⁶

  
  


• 
  

  The goal is to achieve and maintain a lifelong SBP <140 mm Hg and a DBP <90 mm Hg if tolerated.^{6 11 14}

  
  


• 
  

  The goal in hypertensive patients with diabetes mellitus or renal impairment is to achieve and maintain an SBP <130 mm Hg and a DBP <80 mm Hg.^{6 11 14 15}

  
  

Attention Deficit Hyperactivity Disorder

• 
  

  Monitor BP, especially during initial dosage adjustment;⁹ some experts also recommend ECG monitoring.¹⁰

  
  

Administration

Oral Administration

Minimize adverse effects (e.g., somnolence) by administering guanfacine initially at bedtime.¹

Dosage

Available as guanfacine hydrochloride; dosage expressed in terms of guanfacine.¹

Pediatric Patients

Hypertension

Oral

Children ≥12 years of age: Initially, 1 mg daily.¹

If a satisfactory response is not obtained after 3–4 weeks of therapy, may increase dosage to 2 mg once daily at bedtime, although most of the antihypertensive effect is observed at a dosage of 1 mg daily.^{1 5}

Although higher dosages (i.e., >2 mg daily) have been used, dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2}

Attention Deficit Hyperactivity Disorder†

Oral

Children 7–14 years of age: Initially, 0.5 mg daily (given as a single dose at bedtime) has been administered.⁹

Dosage has been increased with caution over 2–4 weeks (e.g., by 0.5 mg every 4 days) to a maximum of 4 mg daily in 3 divided doses.⁹

Adults

Hypertension

Oral

Initially, 1 mg daily.¹

If a satisfactory response is not obtained after 3–4 weeks of therapy, may increase dosage to 2 mg once daily at bedtime, although most of the antihypertensive effect is observed at a dosage of 1 mg daily.^{1 5}

Although higher dosages (i.e., >2 mg daily) have been used, dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2}

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Children ≥12 years of age: Dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2 5}

Attention Deficit Hyperactivity Disorder†

Oral

Children 7–14 years of age: Maximum 4 mg daily.^{9 10 16}

Adults

Hypertension

Oral

Dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2 5}

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

Administer dosages at the low end of the dosing range in patients with renal impairment.^{1 16 16}

May administer usual doses (possibly at low end of dosing range) in patients undergoing dialysis, because limited amounts of the drug are removed by dialysis.¹

Geriatric Patients

Select dosage with caution (usually starting at the low end of the dosing range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Tenex

Contraindications

• 
  

  Known hypersensitivity to the drug.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Rash

Skin rash with exfoliation reported.¹ Although causal relationship to guanfacine not established, discontinue drug if rash occurs and appropriately monitor patient.¹

General Precautions

Withdrawal Effects

Risk of symptoms of nervousness and anxiety and, less commonly, rebound hypertension, if drug is stopped abruptly.¹ Occurs less commonly than with clonidine;^{1 2 3} incidence may be about 3%.²

Following abrupt discontinuance of guanfacine, BP usually returns to pretreatment levels slowly (within 2–4 days) without ill effects.^{1 3} When rebound hypertension occurs, onset typically is 2–4 days after discontinuance of the drug (which is later than observed with clonidine hydrochloride).¹

Cardiovascular Effects

Like other antihypertensive agents, use with caution in patients with severe coronary insufficiency, recent AMI, or cerebrovascular disease.¹

Nervous System Effects

Risk of dose-related sedation/drowsiness, especially during initial therapy.¹ Performance of activities requiring mental alertness and physical coordination (operating machinery, driving a motor vehicle) may be impaired.¹

Specific Populations

Pregnancy

Category B.¹

Not recommended for the treatment of acute hypertension associated with toxemia of pregnancy.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy for management of hypertension not established in children <12 years of age; use not recommended.¹

Safe use for the management of ADHD in children has not been established, but clinical studies currently are under way to determine safety and efficacy.^{9 10}

Mania and aggressive behavioral changes reported in pediatric patients with ADHD receiving the drug;¹ all patients had medical or family risk factors for bipolar disorder.¹ All patients recovered following discontinuance of the drug.¹

Geriatric Use

Clinical trial data for patients ≥65 years of age insufficient to determine whether geriatric patients respond differently than younger adults. ¹ Other experience suggests that response is similar to that in younger adults.¹

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Hepatic Impairment

Like other antihypertensive agents, use guanfacine with caution in patients with chronic hepatic failure.¹

Renal Impairment

Like other antihypertensive agents, use with caution in patients with chronic renal failure.¹

Common Adverse Effects

Dry mouth,^{1 4 5} somnolence,^{1 3 4 5} dizziness,^{1 4 5} constipation,¹ fatigue,^{1 4 5} asthenia,^{1 5} impotence,^{1 4 5} headache.^{1 4 5}

Interactions for Tenex

Drugs Affecting Hepatic Microsomal Enzymes

In a limited number of patients with renal impairment, concomitant administration of guanfacine with a known microsomal enzyme inducer (phenobarbital or phenytoin) resulted in decreased elimination half-life and plasma concentrations of guanfacine.¹ More frequent dosing of guanfacine may be required in patients receiving such concomitant therapy.¹ (See Specific Drugs under Interactions.) Taper dosage of guanfacine when the drug is to be discontinued in patients receiving microsomal enzyme inducers; may avoid rebound hypertension or other symptoms.¹

Specific Drugs

Drug	Interaction	Comments
Anticoagulants	Pharmacokinetic interaction unlikely1
Antigout drugs	Pharmacokinetic interaction unlikely1
Antilipemic agents	Pharmacokinetic interaction unlikely1
β-Adrenergic blocking agents	Pharmacokinetic interaction unlikely1
Bronchodilators	Pharmacokinetic interaction unlikely1
Cardiac drugs (glycosides, coronary vasodilators)	Pharmacokinetic interaction unlikely1
CNS depressants (barbiturates, benzodiazepines, phenothiazines)	May potentiate CNS depression1	Use concomitantly with caution1
Contraceptives (oral)	Pharmacokinetic interaction unlikely1
Cough and cold preparations	Pharmacokinetic interaction unlikely1
Diuretics	Additive/potentiated hypotensive effect1 Pharmacokinetic interaction unlikely1	Usually used to therapeutic advantage in antihypertensive therapy1
Hypoglycemic agents (oral or insulin)	Pharmacokinetic interaction unlikely1
NSAIAs	Pharmacokinetic interaction unlikely1
Phenobarbital	Decreased elimination half-life and plasma concentration of guanfacine in patients with renal failure; 1 withdrawal reaction may occur1 2	In patients receiving phenobarbital, carefully taper guanfacine dosage when drug is to be discontinued1
Phenytoin	Decreased elimination half-life and plasma concentration of guanfacine in patients with renal failure; 1 withdrawal reaction may occur1	In patients receiving phenytoin, carefully taper guanfacine dosage when drug is to be discontinued 1

Tenex Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability is about 80%.¹ Peak plasma concentrations usually attained within 1–4 hours (average: 2.6 hours).¹

Duration

BP response persists ≤24 hours following single oral dose.¹

Distribution

Extent

Extensively distributed to tissues.^{1 2} Highest concentrations in highly perfused organs (e.g., kidney, liver); lower concentrations in the brain, testis, and plasma.²

Crosses the placenta in rats; not known whether crosses placenta in humans.¹

Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

Approximately 70%.¹

Elimination

Metabolism

Approximately 50–70% of a dose is metabolized rapidly in the liver,^{1 2} mainly by oxidative metabolism of the aromatic ring to form the inactive 3-hydroxy derivative (major metabolite),^{1 2} which undergoes conjugation.²

Elimination Route

It appears that the drug is excreted by tubular secretion.¹

In patients with normal renal function, eliminated principally in the urine as unchanged drug (about 50%; range: 40–75%),¹ with remainder eliminated mostly as glucuronide (30–40%) or sulfate (8%).²

Half-life

In patients with normal renal function: about 17 hours (range: 10–30 hours).^{1 2}

Special Populations

Clearance reduced in patients with renal impairment; however, plasma concentrations of drug only slightly increased.¹

Within the reported range of elimination half-lives (10–30 hours), elimination half-life tends to be shorter (13–14 hours) in younger patients and longer (in the upper end of the range) in older patients.¹

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 15–30°C.¹

ActionsActions

• 
  

  Appears to stimulate α₂-adrenergic receptors in the CNS, causing inhibition of sympathetic vasomotor centers.^{1 2} Contributes predominantly to hypotensive effects.^{1 2}

  
  


• 
  

  Central effects result in reduced peripheral sympathetic nerve impulses from the vasomotor center to the heart and blood vessels, resulting in a decrease in peripheral vascular resistance and a reduction in heart rate.¹

  
  


• 
  

  Under conditions of rest or exercise, cardiac output is not altered.¹

  
  


• 
  

  Reduces BP in both supine and standing positions;¹ hypotensive effects may be somewhat greater in the standing position.²

  
  


• 
  

  Peripheral effects (stimulation of peripheral α₂-adrenergic receptors) also may contribute to hypotensive effects.²

  
  


• 
  

  Lowers elevated plasma renin activity and plasma catecholamine concentrations in patients with hypertension, although these effects do not correlate with individual hypotensive responses.^{1 2}

  
  


• 
  

  Acute administration stimulates release of growth hormone, but the drug does not produce sustained elevation of growth hormone during chronic administration.^{1 2}

  
  


• 
  

  Does not affect plasma aldosterone, mean body weight, or electrolytes; slight but insignificant increase in plasma volume observed after 1 month of therapy.¹

  
  


• 
  

  Reduces serum prolactin concentrations in hypertensive patients with elevated serum prolactin concentrations.²

  
  


• 
  

  Enhances neurologic activity in the prefrontal cortex, an area of the brain involved in planning, impulse control, and organization.¹⁰ Shown in nonhuman primates to improve prefrontal cortical function through direct action on postsynaptic α_2A-adrenergic receptors located in the prefrontal cortex.⁹

  
  


• 
  

  Sedative effects, which are less severe than those seen with clonidine,^{3 9} are the result of inhibitory effects on noradrenergic locus ceruleus neurons and direct effects on the thalamus.⁹

  
  

Advice to Patients

• 
  

  Importance of advising patients not to discontinue therapy abruptly because of the risk of withdrawal symptoms (e.g., nervousness, anxiety) and, less commonly, rebound hypertension.¹ (See Withdrawal Effects under Cautions.)

  
  


• 
  

  Importance of advising patients to exercise caution when operating dangerous machinery or driving motor vehicles until it is known that the drug is not causing untoward dizziness or drowsiness.¹

  
  


• 
  

  Importance of advising patients of the potential for decreased tolerance for alcohol and other CNS depressants.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Guanfacine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1 mg (of guanfacine)*	Guanfacine Hydrochloride Tablets
			Tenex	Reddy
		2 mg (of guanfacine)*	Guanfacine Hydrochloride Tablets
			Tenex	Reddy

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Guanfacine HCl 1MG Tablets (MYLAN): 30/$20.99 or 90/$60.99

Guanfacine HCl 2MG Tablets (MYLAN): 30/$25.99 or 90/$75.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Watson Laboratories, Inc. Guanfacine hydrochloride tablets prescribing information. Corona, CA; 2003 Apr.

2. Cornish LA. Guanfacine hydrochloride: a centrally acting antihypertensive agent. Clin Pharm. 1988; 7:187-97. [PubMed 3281788]

3. Wilson MF, Haring G, Lewin A et al. Comparison of guanfacine versus clonidine for efficacy, safety, and occurrence of withdrawal syndrome in step-2 treatment of mild to moderate essential hypertension. Am J Cardiol. 1986; 57:E43-49.

4. Wilson MF, Blackshear J, Parsons OA et al. Antihypertensive efficacy of guanfacine and methyldopa in patients with mild to moderate essential hypertension. J Clin Pharmacol. 1991; 31:318-26. [PubMed 2037703]

5. Materson BJ, Kessler WB, Alderman MH et al. A multicenter, randomized, double-blind dose-response evaluation of step-2 guanfacine versus placebo in mild to moderate hypertension. Am J Cardiol. 1986; 57:E32-37.

6. National Heart, Lung, and Blood Institute National High BP Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289:2560-72.

7. The Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. 1999 guidelines for the management of hypertension. J Hypertension. 1999; 17:392-403.

8. National Heart, Lung, and Blood Institute National High BP Education Program Coordinating Committee. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC 7) Complete Version. Bethesda, MD: 2003 Nov 5. Hypertension. 2003; 42:1206-52. [PubMed 14656957]

9. Scahill L, Chappell PB, Kim YS et al. A placebo-controlled study of guanfacine in the treatment of children with tic disorders and attention deficit hyperactivity disorder. Am J Psychiatry. 2001; 158:1067-74. [PubMed 11431228]

10. Yan J. Nonstimulant ADHD medication moves closer to FDA approval. Psychiatr News. 2007; 42:18.

11. National Heart, Lung, and Blood Institute National High BP Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

12. Izzo JL, Levy D, Black HR. Importance of systolic BP in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

13. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

14. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

15. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2. [PubMed 12502624]

16. Reviewers’ comments (personal observations.)

More Tenex resources

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

• Tenex Prescribing Information (FDA)


• Tenex MedFacts Consumer Leaflet (Wolters Kluwer)


• Tenex Advanced Consumer (Micromedex) - Includes Dosage Information


• Guanfacine Professional Patient Advice (Wolters Kluwer)


• Guanfacine Prescribing Information (FDA)


• Intuniv Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Intuniv Prescribing Information (FDA)


• Intuniv Consumer Overview

Compare Tenex with other medications

• High Blood Pressure

Tylenol Cold Head Congestion

Pronunciation: a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin /FEN-il-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine
Brand Name: Examples include Tylenol Cold Head Congestion and Tylenol Cold Multi Symptom

Tylenol Cold Head Congestion is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tylenol Cold Head Congestion is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tylenol Cold Head Congestion if:

• you are allergic to any ingredient in Tylenol Cold Head Congestion


• you have severe high blood pressure, rapid heartbeat, severe heart blood vessel disease, or other severe heart problems


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tylenol Cold Head Congestion:

Some medical conditions may interact with Tylenol Cold Head Congestion. 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 a history of glaucoma, an enlarged prostate or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, liver problems, or severe kidney problems, or if you drink 3 or more drinks with alcohol per day


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you smoke or have a history of addiction to alcohol

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of Tylenol Cold Head Congestion's side effects may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Tylenol Cold Head Congestion


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Tylenol Cold Head Congestion

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Cold Head Congestion 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 Tylenol Cold Head Congestion:

Use Tylenol Cold Head Congestion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol Cold Head Congestion may be taken with or without food.


• Drink plenty of water while taking Tylenol Cold Head Congestion.


• If you miss a dose of Tylenol Cold Head Congestion, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Cold Head Congestion.

Important safety information:

• Tylenol Cold Head Congestion may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol Cold Head Congestion with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you use Tylenol Cold Head Congestion unless your doctor tells you to.


• Tylenol Cold Head Congestion contains acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• Tylenol Cold Head Congestion may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Cold Head Congestion. Talk to your doctor before you take Tylenol Cold Head Congestion or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Tylenol Cold Head Congestion may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tylenol Cold Head Congestion.


• Tell your doctor or dentist that you take Tylenol Cold Head Congestion before you receive any medical or dental care, emergency care, or surgery.


• Use Tylenol Cold Head Congestion with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Tylenol Cold Head Congestion in CHILDREN; they may be more sensitive to its effects.


• Different brands of Tylenol Cold Head Congestion may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: It is not known if Tylenol Cold Head Congestion can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Cold Head Congestion while you are pregnant. It is not known if Tylenol Cold Head Congestion is found in breast milk. Do not breast-feed while taking Tylenol Cold Head Congestion.

Possible side effects of Tylenol Cold Head Congestion:

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: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

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: Tylenol Cold Head Congestion 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. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Tylenol Cold Head Congestion:

Store Tylenol Cold Head Congestion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Cold Head Congestion out of the reach of children and away from pets.

General information:

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


• Tylenol Cold Head Congestion 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 Tylenol Cold Head Congestion. 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 Tylenol Cold Head Congestion resources

• Tylenol Cold Head Congestion Side Effects (in more detail)
• Tylenol Cold Head Congestion Use in Pregnancy & Breastfeeding
• Tylenol Cold Head Congestion Drug Interactions
• 0 Reviews for Tylenol Cold Head Congestion - Add your own review/rating

Compare Tylenol Cold Head Congestion with other medications

• Cold Symptoms
• Influenza

Lortab Liquid

Pronunciation: a-SEET-a-MIN-oh-fen/HYE-droe-KOE-done
Generic Name: Acetaminophen/Hydrocodone
Brand Name: Examples include Hycet and Lortab

Lortab Liquid contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Lortab Liquid is used for:

Treating moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.

Lortab Liquid is an analgesic combination. Acetaminophen works by lowering a chemical in the brain that stimulates pain nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers." The combination may provide better pain relief than either medicine alone.

Do NOT use Lortab Liquid if:

• you are allergic to any ingredient in Lortab Liquid


• you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)


• you are taking sodium oxybate (GHB)

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

Before using Lortab Liquid:

Some medical conditions may interact with Lortab Liquid. 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 are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)


• if you have or have ever had alcoholism, substance abuse, narcotic dependence, or if you consume more than 3 alcoholic drinks per day


• if you have a history of suicidal thoughts or behaviors


• if you have a head injury, increased pressure in the head, a brain injury or tumor, epilepsy, or seizures


• if you are having an asthma attack


• if you have an acute stomach or intestinal problem, chronic inflammation and ulceration of the bowel, or you have had recent abdominal surgery


• if you have adrenal gland problems; enlargement of the prostate gland; heart failure or lung disease, including shortness of breath; liver or kidney problems; thyroid disease; urinary blockage; or viral hepatitis

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

• Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because serious side effects, such as increased sleepiness and decreased ability to breathe, may occur


• Naltrexone because it may decrease the effectiveness of Lortab Liquid and withdrawal symptoms may occur in patients who have become physically dependent on opioids

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lortab Liquid 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 Lortab Liquid:

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

• An extra patient leaflet is available with Lortab Liquid. Talk to your pharmacist if you have questions about this information.


• Take Lortab Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Lortab Liquid, take 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 take 2 doses at once.

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

Important safety information:

• Lortab Liquid may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Lortab Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lortab Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Lortab Liquid may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Lortab Liquid has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Lortab Liquid may harm your liver. Your risk may be greater if you drink alcohol while you are using Lortab Liquid. Talk to your doctor before you take Lortab Liquid or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Use Lortab Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially possible decreased breathing and drowsiness.


• Lortab Liquid should not be used in CHILDREN; safety and effectiveness in 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 Lortab Liquid while you are pregnant. Lortab Liquid is found in breast milk. Do not breast-feed while taking Lortab Liquid.

When used for long periods of time or at high doses, Lortab Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Lortab Liquid stops working well. Do not take more than prescribed.

Some people who use Lortab Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Lortab Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Lortab Liquid:

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:

Blurred vision; constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.

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); anxiety; change in the amount of urine; fear; hearing change or loss; interrupted breathing; mental or mood changes; unusual tiredness.

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: Lortab 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. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure; stomach or intestinal pain.

Proper storage of Lortab Liquid:

Store Lortab Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not freeze. Dispense in a tight, light-resistant container. Do not store in the bathroom. Keep Lortab Liquid out of the reach of children and away from pets.

General information:

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


• Lortab Liquid 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 Lortab Liquid. 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 Lortab resources

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

Compare Lortab with other medications

• Back Pain
• Cough
• Pain
• Rheumatoid Arthritis

Tobi inhalation

Generic Name: tobramycin (inhalation) (toe bra MY sin)

Brand Names: Tobi

What is tobramycin?

Tobramycin is an antibiotic. It fights bacteria in the body.

Tobramycin inhalation is inhaled into the lungs using a nebulizer. Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis.

Tobramycin may also be used for purposes other than those listed here.

What is the most important information I should know about tobramycin?

Notify your doctor immediately if you develop ringing in the ears, dizziness, or changes in hearing during treatment with tobramycin.

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

What should I discuss with my healthcare provider before using tobramycin?

Do not use tobramycin without first talking to your doctor if you have had an allergic reaction to an aminoglycoside antibiotic such as tobramycin (Nebcin, Tobi), gentamicin (Garamycin, others), amikacin (Amikin), kanamycin (Kantrex), streptomycin, paromomycin, or neomycin.

Talk to your doctor before using tobramycin if you have

• 
  

  hearing problems;

  
  


• 
  

  a neuromuscular disease such as myasthenia gravis or Parkinson's disease; or

  
  


• kidney disease.

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tobramycin is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Tobramycin is known to cause deafness in the baby when taken during pregnancy. Do not use tobramycin without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether tobramycin passes into breast milk. Do not use tobramycin without first talking to your doctor if you are breast-feeding a baby.

How should I use tobramycin?

Use tobramycin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Tobramycin is inhaled into the lungs with the use of a nebulizer. Do not swallow the solution by mouth.

Wash your hands with soap and water before preparing each treatment.

To use tobramycin inhalation:

• 
  

  Set up the nebulizer as directed.

  
  


• 
  

  Open one ampule of tobramycin solution for inhalation and squeeze the contents of the ampule into the nebulizer cup. Replace the nebulizer top.

  
  


• 
  

  Turn on the compressor. Check for a steady mist from the mouthpiece. If there is no mist, check all tubing connections and make sure the compressor is working.

  
  


• 
  

  Sit or stand in a position that will allow you to breathe normally. Place the mouthpiece of the nebulizer between your teeth and above your tongue and breathe normally only through your mouth. A noseclip may help you to breathe only through your mouth during a treatment. Continue breathing through the mouthpiece until all of the medicine is gone and no more mist is being produced. You may hear a sputtering sound when the nebulizer cup is empty. The entire treatment should take approximately 15 minutes to complete.

  
  


• 
  

  If you are interrupted or need to cough or rest during a treatment, turn the compressor off to save the medication. Turn the compressor back on when you are ready to resume treatment.

  
  

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

If you are using several respiratory medications, the recommended order is bronchodilator first, followed by chest physiotherapy, then other inhaled medications, followed by tobramycin.

Do not use tobramycin that is cloudy or that has particles in it. Tobramycin stored at room temperature may become a darker color of yellow. This does not indicate any change in quality of the medication. Do not mix tobramycin with dornase alfa (Pulmozyme) or any other medications in the nebulizer.

Do not use tobramycin in bigger doses or more often than prescribed.

Use all of the tobramycin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Store tobramycin in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). If refrigeration is not available (e.g., when traveling), tobramycin may be stored at room temperature (77 degrees Fahrenheit/25 degrees Celsius) for up to 28 days. Avoid exposing ampules of tobramycin to direct light. Do not use tobramycin beyond the expiration date printed on the ampule.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is less than six hours until the next scheduled dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a tobramycin overdose may include dizziness, ringing in the ears, loss of hearing, difficulty or decreased breathing, and weakness.

What should I avoid while using tobramycin?

Do not mix tobramycin with dornase alfa (Pulmozyme) in the nebulizer.

Tobramycin side effects

If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  ringing in the ears or changes in hearing;

  
  


• 
  

  dizziness;

  
  


• 
  

  new or worsening respiratory problems or difficulty breathing;

  
  


• 
  

  muscle weakness; or

  
  


• 
  

  a rash.

  
  

If you experience any of the following less serious side effects, continue using tobramycin and talk to your doctor:

• 
  

  changes in voice; or

  
  


• 
  

  unpleasant taste or odor of the medication.

  
  

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 tobramycin?

Before using tobramycin, tell your doctor if you are taking:

• 
  

  furosemide (Lasix);

  
  


• 
  

  ethacryinc acid (Edecrin); or

  
  


• 
  

  mannitol (Osmitrol).

  
  

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Do not mix tobramycin with dornase alfa (Pulmozyme) in the nebulizer.

Drugs other than those listed here may also interact with tobramycin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Tobi resources

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

Compare Tobi with other medications

• Bacteremia
• Bacterial Infection
• Bone infection
• Burns, External
• Cystic Fibrosis
• Endocarditis
• Febrile Neutropenia
• Intraabdominal Infection
• Kidney Infections
• Meningitis
• Peritonitis
• Pneumonia
• Rabbit Fever
• Sepsis
• Shunt Infection
• Skin Infection

Where can I get more information?

• Your pharmacist has additional information about tobramycin written for health professionals that you may read.

See also: Tobi side effects (in more detail)

Equalactin

Generic Name: polycarbophil (POL ee KAR boe fil)

Brand Names: Equalactin, Fiber Lax, FiberCon, Fiberlax, Fibernorm, Konsyl Fiber, Perdiem Fiber Caplet

What is Equalactin (polycarbophil)?

Polycarbophil is a bulk-forming laxative that increases the amount of water in your stools to help make them softer and easier to pass.

Polycarbophil is used to treat constipation and to help maintain regular bowel movements.

Polycarbophil may also be used in some cases to treat diarrhea or irritable bowel syndrome.

Polycarbophil may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Equalactin (polycarbophil)?

You should not use this medication if you are allergic to polycarbophil or to mineral oil, sodium laurel sulfate, or povidone (such as Betadine).

Before using polycarbophil, tell your doctor if you are allergic to any drugs, or if you have trouble swallowing, a blockage in your intestines, stomach pain with nausea or vomiting, a history of bleeding from your rectum, or a sudden change in your bowel habits that has lasted for 2 weeks or longer.

Ask your doctor before taking polycarbophil if you are pregnant or breast-feeding. The polycarbophil tablet may expand in your throat and cause you to choke if you do not use enough liquid to help swallow the pill. Be sure to drink a full 8-ounce glass of water or other liquid while swallowing the regular tablet or after chewing the chewable tablet.

Polycarbophil is usually taken up to 4 times per day. Do not take more than recommended by your doctor or listed on the medicine label.

Polycarbophil should cause you to have a bowel movement within 12 to 72 hours.

Do not take polycarbophil for longer than 7 days unless your doctor tells you to.

What should I discuss with my health care provider before taking Equalactin (polycarbophil)?

You should not use this medication if you are allergic to polycarbophil or to mineral oil, sodium laurel sulfate, or povidone (such as Betadine).

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

• 
  

  trouble swallowing;

  
  


• 
  

  a blockage in your intestines;

  
  


• 
  

  stomach pain with nausea or vomiting;

  
  


• 
  

  a history of bleeding from your rectum; or

  
  


• 
  

  a sudden change in your bowel habits that has lasted for 2 weeks or longer.

  
  

If you have any of these conditions, you may not be able to take polycarbophil, or you may need a dose adjustment or special tests during treatment.

Ask your doctor before taking polycarbophil if you are pregnant or breast-feeding.

Some forms of polycarbophil may contain phenylalanine. Talk to your doctor before using this medication if you have phenylketonuria (PKU).

Do not give this medicine to a young child without the advice of a doctor.

How should I take Equalactin (polycarbophil)?

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

Take this medicine with a full glass (8 ounces) of water or other liquid. The tablet may expand in your throat and cause you to choke if you do not use enough liquid to help swallow the pill. Unless you need to restrict your fluid intake, drink plenty of fluids each day while you are taking polycarbophil.

The chewable tablet must be chewed before your swallow it.

Older adults may be more likely to choke while taking this medication. Be sure to drink a full glass of water while swallowing the regular tablet, or after chewing the chewable tablet.

Polycarbophil is usually taken up to 4 times per day. Do not take more of this medicine than recommended by your doctor or printed on the medicine label.

Polycarbophil should cause you to have a bowel movement within 12 to 72 hours. Call your doctor if your constipation does not improve after 3 days of taking this medication.

Do not take polycarbophil for longer than 7 days unless your doctor tells you to. Overuse of a laxative may cause damage to the nerves, muscles, or tissues in your intestines. Store polycarbophil at room temperature away from moisture and heat.

What happens if I miss a dose?

Since polycarbophil is usually taken as needed, you will not be on a long-term dosing schedule. If you are taking the medication daily for up to 7 days, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of polycarbophil is not likely to produce life-threatening side effects.

What should I avoid while taking Equalactin (polycarbophil)?

Avoid taking polycarbophil within 2 hours before or after you take any other medications. A laxative can make it harder for your body to absorb other medicines.

Equalactin (polycarbophil) 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. Stop using polycarbophil and call your doctor at once if you have a serious side effect such as:

• 
  

  vomiting;

  
  


• 
  

  choking on the tablet;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  chest pain; or

  
  


• 
  

  rectal bleeding.

  
  

Less serious side effects may include:

• 
  

  mild stomach pain;

  
  


• 
  

  bloating; or

  
  


• 
  

  gas.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Equalactin (polycarbophil)?

There may be other drugs that can interact with polycarbophil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Equalactin resources

• Equalactin Drug Interactions
• Equalactin Support Group
• 0 Reviews for Equalactin - Add your own review/rating

Compare Equalactin with other medications

• Constipation

Where can I get more information?

• Your pharmacist can provide more information about polycarbophil.