Trobicin

spectinomycin

Dosage Form: injectable suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Trobicin Sterile Powder and other antibacterial drugs, Trobicin Sterile Powder should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

For intramuscular Injection

Trobicin Description

Trobicin Sterile Powder contains spectinomycin hydrochloride which is an aminocyclitol antibiotic produced by a species of soil microorganism designated as Streptomyces spectabilis. Sterile spectinomycin hydrochloride is the pentahydrated dihydrochloride salt of spectinomycin. The structural formula is represented below:

Spectinomycin hydrochloride is isolated as a white to pale buff crystalline dihydrochloride pentahydrate powder, molecular weight 495, and is stable in the dry state for 36 months.

Trobicin - Clinical Pharmacology

Trobicin Sterile Powder is rapidly absorbed after intramuscular injection. A single, two-gram injection produces peak serum concentrations averaging about 100 mcg/mL at one hour; a single, four-gram injection produces peak serum concentrations averaging 160 mcg/mL at two hours. Average serum concentrations of 15 mcg/mL for the two-gram dose and 31 mcg/mL for the four-gram dose were present eight hours after dosing.

Microbiology

Spectinomycin hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit.

In vitro studies have shown spectinomycin hydrochloride to be active against most strains of Neisseria gonorrhoeae (minimum inhibitory concentration <7.5 to 20 mcg/mL).

Definitive in vitro studies have shown no cross-resistance of N. gonorrhoeae between spectinomycin hydrochloride and penicillin. The antibiotic is not significantly bound to plasma protein.

Indications and Usage for Trobicin

Trobicin Sterile Powder is indicated in the treatment of acute gonorrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of Neisseria gonorrhoeae. Men and women with known recent exposure to gonorrhea should be treated as those known to have gonorrhea.

The in vitro susceptibility of Neisseria gonorrhoeae to spectinomycin hydrochloride can be tested by agar diluted methods. Trobicin Susceptibility Powder is available for this purpose and its package insert should be consulted for details.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Trobicin Sterile Powder and other antibacterial drugs, Trobicin Sterile Powder should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

The use of Trobicin Sterile Powder is contraindicated in patients previously found hypersensitive to it.

Warnings

Spectinomycin hydrochloride is not effective in the treatment of syphilis. Antibiotics used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Since the treatment of syphilis demands prolonged therapy with any effective antibiotic, patients being treated for gonorrhea should be closely observed clinically. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with spectinomycin hydrochloride should have a follow-up serologic test for syphilis after three months.

Contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants and an increased incidence of neurologic and other complications.

Precautions

The usual precautions should be observed with atopic individuals.

The clinical effectiveness of Trobicin Sterile Powder should be monitored to detect evidence of development of resistance by Neisseria gonorrhoeae.

Prescribing Trobicin Sterile Powder in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be counseled that antibacterial drugs including Trobicin Sterile Powder should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Trobicin Sterile Powder is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Trobicin Sterile Powder or other antibacterial drugs in the future.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Genotoxicity of spectinomycin hydrochloride was evaluated in six assay test systems including two Ames tests, two micronucleus tests in mice, unscheduled DNA synthesis in rat primary hepatocytes, and a chromosomal aberration test in Chinese hamster ovary cells. Spectinomycin was not shown to be mutagenic or genotoxic in these tests.

No adverse effects on fertility or general reproductive performance were observed when spectinomycin was administered subcutaneously to rats at dose levels up to 300 mg/kg (equivalent to the recommended maximum human dose based on mg/m2). A three-generation reproduction study in rats administered spectinomycin hydrochloride orally at dose levels up to 400 mg/kg (equivalent to the recommended maximum human dose based on mg/m2) produced no evidence of drug-induced toxicity during growth, gestation, or lactation periods of any parental generation. Pregnancy rates of the 400 mg/kg/day groups were consistently lower than those of the control groups. A histopathological examination of the testes and ovaries of the third generation animals was normal.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Spectinomycin was not teratogenic or embryocidal when orally or subcutaneously administered to rats at doses of 300 mg/kg/day (equivalent to the recommended maximum human dose based on mg/m2). No teratogenic effects were observed when spectinomycin was administered intraperitoneally to mice or rats at dose levels of 400 or 1600 mg/kg/day, respectively. Spectinomycin was administered intramuscularly or subcutaneously to pregnant rabbits at dose levels up to 300 mg/kg/day (equivalent to the recommended maximum human dose based on mg/m2). Embryonic and fetal development were unaffected by treatment. Since there are no controlled studies of spectinomycin in pregnant women, and because animal reproduction studies are not always predictive of human responses, spectinomycin should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when spectinomycin is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. (See WARNINGS.)

Adverse Reactions

The following reactions were observed during the single dose clinical trials: soreness at the injection site, urticaria, dizziness, nausea, chills, fever and insomnia.

During multiple dose subchronic tolerance studies in normal human volunteers, the following were noted: a decrease in hemoglobin, hematocrit and creatinine clearance; elevation of alkaline phosphatase, BUN and SGPT. In single and multiple dose studies in normal volunteers, a reduction in urine output was noted. Extensive renal function studies demonstrated no consistent changes indicative of renal toxicity.

A few cases of anaphylaxis or anaphylactoid reactions have been reported. If serious allergic reactions occur, the usual agents (epinephrine, corticosteroids, and/or antihistamines) should be available for emergency use. In cases of severe anaphylaxis, airway support and oxygen may also be required.

Overdosage

Information on overdosage in humans is not available. Hemodialysis has been reported to aid in the removal of intravenously administered spectinomycin from the body.

Kusumi R, Metzler C, Fass R; Pharmacokinetics of Spectinomycin in Volunteers with Renal Insufficiency, Chemotherapy, 27:95–98 (1981).

Trobicin Dosage and Administration

Preparation of Drug for Intramuscular Injection

Trobicin Sterile Powder, 2 grams: reconstitute with 3.2 mL of the accompanying diluent.1

Shake vials vigorously immediately after adding diluent and before withdrawing dose. It is recommended that disposable syringes and needles be used to avoid contamination with penicillin residue, especially when treating patients known to be highly sensitive to penicillin. Use of a 20-gauge needle is recommended.

1

Bacteriostatic Water for Injection with Benzyl Alcohol 0.945% w/v added as preservative.

Dosage

Intramuscular injections should be made deep into the upper outer quadrant of the gluteal muscle.

Adults (Men and Women)—Inject 5 mL intramuscularly for a 2-gram dose. This is also the recommended dose for patients being treated after failure of previous antibiotic therapy.

In geographic areas where antibiotic resistance is known to be prevalent, initial treatment with 4 grams (10 mL) intramuscularly is preferred. The 10-mL injection may be divided between two gluteal injection sites.

STORAGE CONDITIONS

Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store prepared suspension at controlled room temperature 20° to 25°C (68° to 77°F) and use within 24 hours.

How is Trobicin Supplied

Contains benzyl alcohol. (See WARNINGS.)

Trobicin Sterile Powder is available as:

Trobicin Sterile Powder, 2-gram vial NDC 0009-0566-01—with one ampoule of Bacteriostatic Water for Injection with Benzyl Alcohol 0.945% w/v added as preservative. When reconstituted with 3.2 mL of the accompanying diluent, each vial yields a sufficient quantity for withdrawal of 5 mL of a suspension containing 400 mg spectinomycin per mL (as the hydrochloride). Five mL provides 2 grams spectinomycin. For intramuscular use only.

Trobicin Susceptibility Powder—100 mg. See package insert for in vitro testing procedure.

Rx only

LAB-0230-3.0

Revised August 2006

Trobicin  spectinomycin  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-0566

Packaging # NDC Package Description Multilevel Packaging 1 0009-0566-01 1 KIT In 1 PACKAGE, COMBINATION None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL   5 MILLILITER  in 1  Part 2 1 AMPULE   3.2 MILLILITER  in 1

Part 1 of 2 Trobicin  spectinomycin hydrochloride  injection, powder, for suspension

Product Information       Route of Administration INTRAMUSCULAR DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength spectinomycin hydrochloride (spectinomycin) Active 400 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 5 mL (MILLILITER) In 1 VIAL None

Part 2 of 2 BACTERIOSTATIC WATER  water  injection, solution

Product Information       Route of Administration INTRAMUSCULAR DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Water Inactive   Benzyl Alcohol Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 3.2 mL (MILLILITER) In 1 AMPULE None

Revised: 03/2007Pharmacia and Upjohn, Co.

More Trobicin resources

• Trobicin Side Effects (in more detail)
• Trobicin Drug Interactions
• Trobicin Support Group
• 0 Reviews for Trobicin - Add your own review/rating

• Trobicin Concise Consumer Information (Cerner Multum)


• Trobicin Monograph (AHFS DI)


• Trobicin Advanced Consumer (Micromedex) - Includes Dosage Information


• Spectinomycin Professional Patient Advice (Wolters Kluwer)

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Stalevo 150

Generic Name: carbidopa, entacapone, and levodopa (KAR bi DOE pa, en TAK a pone, LEE voe DOE pa)

Brand Names: Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75

What is Stalevo 150 (carbidopa, entacapone, and levodopa)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels of dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect. Entacapone increases levels of levodopa in the body.

The combination of carbidopa, entacapone, and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.

Carbidopa, entacapone, and levodopa may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Stalevo 150 (carbidopa, entacapone, and levodopa)?

You should not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have narrow-angle glaucoma, unusual skin lesions, or a history of skin cancer.

Tell your doctor about all of your medical conditions, especially heart disease, high blood pressure, asthma or other breathing problems, liver or kidney disease, a hormonal disease, an ulcer, glaucoma, or mental illness. Also tell your doctor about all the medications you use.

It may take up to several weeks of using carbidopa, entacapone, and levodopa before your symptoms improve. Talk with your doctor if your symptoms do not improve or if the effects of this medication seem to wear off quickly in between doses. Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor.

What should I discuss with my healthcare provider before taking Stalevo 150 (carbidopa, entacapone, and levodopa)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have:

• 
  

  narrow-angle glaucoma;

  
  


• 
  

  unusual skin lesions that have not been checked by a doctor; or

  
  


• 
  

  a history of malignant melanoma (skin cancer).

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, or a prior heart attack;

  
  


• 
  

  asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

  
  


• 
  

  kidney disease, liver disease, or bile duct obstruction;

  
  


• 
  

  an endocrine (hormonal) disease;

  
  


• 
  

  a stomach or intestinal ulcer;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  depression or other mental illness.

  
  

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking this medicine.

Carbidopa, entacapone, and levodopa may cause hallucinations (the sensation of hearing or seeing something that is not there). Call your doctor if you experience hallucinations.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether carbidopa, entacapone, and levodopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Carbidopa, entacapone, and levodopa may pass into breast milk and could harm a nursing baby. You should not breast-feed while you are taking carbidopa, entacapone, and levodopa.

How should I take Stalevo 150 (carbidopa, entacapone, and levodopa)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your medicine at regular intervals to keep a steady amount of the drug in your body at all times.

Drink plenty of liquids while you are taking this medication. It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using carbidopa, entacapone, and levodopa.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include weakness, loss of coordination, trouble breathing, fainting, or seizure (convulsions).

What should I avoid while taking Stalevo 150 (carbidopa, entacapone, and levodopa)?

Carbidopa, entacapone, and levodopa may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa, entacapone, and levodopa.

Stalevo 150 (carbidopa, entacapone, and levodopa) 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 a serious side effect such as:

• 
  

  nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);

  
  


• 
  

  depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;

  
  


• 
  

  worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  
  


• 
  

  severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;

  
  


• 
  

  feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;

  
  


• 
  

  tight feeling in your chest, new or worsening cough, fever, trouble breathing;

  
  


• 
  

  easy bruising or bleeding, bloody or tarry stools, coughing up blood;

  
  


• 
  

  pain or burning when you urinate; or

  
  


• 
  

  unexplained muscle pain, tenderness, or weakness.

  
  

Less serious side effects may include:

• 
  

  stomach pain or upset, loss of appetite, constipation;

  
  


• 
  

  dry mouth, changes in your sense of taste;

  
  


• 
  

  unusual skin changes. mild rash or itching;

  
  


• 
  

  dizziness or drowsiness, headache, blurred vision;

  
  


• 
  

  muscle cramps, back pain; or

  
  


• 
  

  agitation or anxiety, sleep problems (insomnia), strange dreams.

  
  

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Stalevo 150 (carbidopa, entacapone, and levodopa)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbidopa, entacapone, and levodopa. Tell your doctor if you regularly use any of these other medicines, or any other Parkinson's medications.

Tell your doctor about all other medicines you use, especially:

• 
  

  apomorphine (Apokyn);

  
  


• 
  

  cholestyramine (Prevalite, Questran);

  
  


• 
  

  dobutamine (Dobutrex);

  
  


• 
  

  epinephrine (Epi-Pen, and others);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  isoproterenol (Isuprel, Medihaler-Iso);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  metoclopramide (Reglan);

  
  


• 
  

  papaverine (Pavabid, Papacon, Pavagen, Pavacot);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  an antibiotic such as ampicillin, chloramphenicol, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others), or rifampin (Rifadin, Rifater, Rifamate);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others.

  
  

This list is not complete and other drugs may interact with carbidopa, entacapone, and levodopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Stalevo 150 resources

• Stalevo 150 Side Effects (in more detail)
• Stalevo 150 Use in Pregnancy & Breastfeeding
• Drug Images
• Stalevo 150 Drug Interactions
• Stalevo 150 Support Group
• 0 Reviews for Stalevo50 - Add your own review/rating

• Stalevo 150 Advanced Consumer (Micromedex) - Includes Dosage Information


• Carbidopa/Entacapone/Levodopa MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Stalevo 150 with other medications

• Parkinson's Disease

Where can I get more information?

• Your pharmacist can provide more information about carbidopa, entacapone, and levodopa.

See also: Stalevo50 side effects (in more detail)

Niacinamide Gel

Pronunciation: NYE-a-sin-a-mide
Generic Name: Niacinamide
Brand Name: Nicomide-T

Niacinamide Gel is used for:

Treating acne.

Niacinamide Gel is a vitamin B supplement. Exactly how Niacinamide Gel works is unknown.

Do NOT use Niacinamide Gel if:

• you are allergic to any ingredient in Niacinamide Gel

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

Before using Niacinamide Gel:

Some medical conditions may interact with Niacinamide Gel. 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 Niacinamide Gel. However, no specific interactions with Niacinamide Gel are known at this time.

Ask your health care provider if Niacinamide Gel 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 Niacinamide Gel:

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

• Wash the affected area with a mild cleanser or other cleansing product prescribed by your doctor and completely dry.


• Apply a thin layer of the medicine to the affected area twice daily or as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• Wash your hands immediately after using Niacinamide Gel.


• If you miss a dose of Niacinamide Gel, 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 Niacinamide Gel.

Important safety information:

• Niacinamide Gel is for external use only. Avoid getting Niacinamide Gel in your eyes. If you get Niacinamide Gel in your eyes, rinse thoroughly with cool tap water.


• Follow up with your doctor after 8 to 12 weeks to monitor your progress.


• Do not use any other medicines or special cleansers on your skin unless your doctor instructs you otherwise. Makeup and other acne medicines may be applied over Niacinamide Gel as directed by your doctor.


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

Possible side effects of Niacinamide Gel:

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:

Dry skin.

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); 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.

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 Niacinamide Gel:

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

General information:

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


• Niacinamide Gel 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 Niacinamide Gel. 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.

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• Niacinamide Use in Pregnancy & Breastfeeding
• Niacinamide Support Group
• 0 Reviews for Niacinamide - Add your own review/rating

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Suprenza

phentermine hydrochloride

Dosage Form: tablet, orally disintegrating
FULL PRESCRIBING INFORMATION

Indications and Usage for Suprenza

Suprenza is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)
Weight (pounds)	5'0"	5'3"	5'6"	5'9"	6'0"	6'3"
140	27	25	23	21	19	18
150	29	27	24	22	20	19
160	31	28	26	24	22	20
170	33	30	28	25	23	21
180	35	32	29	27	25	23
190	37	34	31	28	26	24
200	39	36	32	30	27	25
210	41	37	34	31	29	26
220	43	39	36	33	30	28
230	45	41	37	34	31	29
240	47	43	39	36	33	30
250	49	44	40	37	34	31

The limited usefulness of agents of this class, including Suprenza, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Suprenza Dosage and Administration

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Suprenza is not recommended for use in pediatric patients ≤ 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

With dry hands, gently remove the Suprenza (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.

Dosage Forms and Strengths

Orally disintegrating tablets (ODT) containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side.

Contraindications

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)


• During or within 14 days following the administration of monoamine oxidase inhibitors


• Hyperthyroidism


• Glaucoma


• Agitated states


• History of drug abuse


• Pregnancy [see Use in Specific Populations (8.1)]


• Nursing [see Use in Specific Populations (8.3)]


• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

Warnings and Precautions

Coadministration with Other Drug Products for Weight Loss

Suprenza is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Suprenza and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Suprenza and these drug products is not recommended.

Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Suprenza alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of Suprenza alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Effect on the Ability to Engage in Potentially Hazardous Tasks

Suprenza may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Risk of Abuse and Dependence

Suprenza is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and to other related stimulant drugs that have been extensively abused. The possibility of abuse of Suprenza should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence (9) and Overdosage (10).

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Usage with Alcohol

Concomitant use of alcohol with Suprenza may result in an adverse drug reaction.

Use in Patients with Hypertension

Use caution in prescribing Suprenza for patients with even mild hypertension (risk of increase in blood pressure).

Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections:

 

- Primary pulmonary hypertension [see Warnings and Precautions (5.2)]

 

- Valvular heart disease [see Warnings and Precautions (5.3)]

 

- Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]

 

- Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence (9.3)]

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

Drug Interactions

Monoamine Oxidase Inhibitors

Use of Suprenza is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Alcohol

Concomitant use of alcohol with Suprenza may result in an adverse drug reaction.

Insulin and Oral Hypoglycemic Medications

Requirements may be altered [see Warnings and Precautions (5.9)].

Adrenergic Neuron Blocking Drugs

Suprenza may decrease the hypotensive effect of adrenergic neuron blocking drugs.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category X

Suprenza is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers

It is not known if Suprenza is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Suprenza was not studied in patients with renal impairment. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering Suprenza to patients with renal impairment [see Clinical Pharmacology (12.3)].

Drug Abuse and Dependence

Controlled Substance

Phentermine is a Schedule IV controlled substance.

Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

Chronic Intoxication

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence (9.3).

Suprenza Description

Suprenza is an orally disintegrating tablet (ODT) of phentermine hydrochloride, USP. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Suprenza is available as an orally disintegrating tablet (ODT) containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base).

Suprenza contains the inactive ingredients mannitol powder, citric acid powder, Povidone CL, Povidone K 30, sucralose, magnesium stearate, peppermint flavor, talc, sodium lauryl sulfate, and mannitol pregranulated. Suprenza 15 mg ODT also contains FD&C Blue # 1 lake and FD&C Yellow # 5 lake. Suprenza 30 mg ODT also contains FD&C Yellow # 5 lake.

Suprenza - Clinical Pharmacology

Mechanism of Action

Suprenza is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Pharmacodynamics

Typical of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Pharmacokinetics

In terms of rate and extent of exposure, phentermine orally disintegrating tablets are equivalent to phentermine capsules and tablets administered under fasting conditions.

Following the administration of the oral disintegrating tablet (ODT), phentermine reaches peak concentrations (Cmax) after 3.0 to 4.4 hours. Swallowing the ODT after disintegration with or without water did not affect the extent (AUC) of phentermine exposure.

Administration of the ODT after a high fat/high calorie breakfast decreased the Cmax of phentermine by approximately 5% and the AUC by approximately 12%. Despite the decrease in Cmax and AUC, phentermine ODT can be administered with or without food.

Swallowing the ODT without prior disintegration decreased the Cmax of phentermine by approximately 7% and the AUC by approximately 8% compared to swallowing the ODT after disintegration.

Specific Populations

Renal Impairment

Suprenza was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering Suprenza to patients with renal impairment.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with Suprenza to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

Clinical Studies

No clinical studies have been conducted with Suprenza.

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with "anorectic" drugs lost more weight on the average than those treated with placebo and diet.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

How Supplied/Storage and Handling

Available as orally disintegrating tablets (ODT) containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side.

Suprenza is available as described in Table 2.

Table 2. Suprenza Orally Disintegrating Tablet Presentations

Tablet Strength	Tablet Color/Shape	Tablet Markings	NDC Code
15 mg	Round, embossed tablets Yellow with blue spots	AX4 on one side	NDC: 24090 720
30 mg	Round, embossed tablets Yellow	AX7 on one side	NDC: 24090 721

Suprenza 15 mg and 30 mg ODT are packaged in bottles of 30 and 100.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Patient Counseling Information

Patients must be informed that Suprenza is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)].

Patients must be instructed on how much Suprenza to take, and when and how to take it [see Dosage and Administration (3)].

Advise pregnant women and nursing mothers not to use Suprenza (see Use in Specific Populations (8.1, 8.3)].

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

• Development of primary pulmonary hypertension [see Warnings and Precautions (5.2)]


• Development of serious valvular heart disease [see Warnings and Precautions (5.3)]


• Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]


• The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6)]


• The risk of interactions [see Contraindications (4), Warnings and Precautions (5.7, 5.9) and Drug Interactions (7)]

See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4)] and


• the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6), Drug Abuse and Dependence (9), and Overdosage (10)].

Tell patients to keep Suprenza in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Suprenza may harm others and is against the law.

Manufactured by:

Alpex Pharma SA

Lugano, Switzerland

Marketed and Distributed by:

Akrimax Pharmaceuticals, LLC

Cranford, NJ 07016

272F001

PRINCIPAL DISPLAY PANEL - 15 mg ODT Tablets

NDC 24090-720-85

Suprenza™

(Phentermine Hydrochloride)

Orally Disintegrating Tablets

15 mg

Rx Only

30 Tablets

C IV

PRINCIPAL DISPLAY PANEL - 30 mg ODT Tablets

NDC 24090-721-85

Suprenza™

(Phentermine Hydrochloride)

Orally Disintegrating Tablets

30 mg

Rx Only

30 Tablets

C IV

 

Suprenza  phentermine hydrochloride  tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24090-720 (52871-720) Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 15 mg

Inactive Ingredients Ingredient Name Strength MANNITOL   CITRIC ACID MONOHYDRATE   POVIDONE   POVIDONE K30   SUCRALOSE   MAGNESIUM STEARATE   PEPPERMINT   TALC   SODIUM LAURYL SULFATE   FD&C BLUE NO. 1   FD&C YELLOW NO. 5

Product Characteristics Color yellow (yellow) , blue (blue) Score no score Shape ROUND (ROUND) Size 10mm Flavor PEPPERMINT (PEPPERMINT) Imprint Code AX4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24090-720-85 30 TABLET In 1 BOTTLE, PLASTIC None 2 24090-720-77 7 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA202088	12/01/2011

Suprenza  phentermine hydrochloride  tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24090-721 (52871-721) Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength MANNITOL   CITRIC ACID MONOHYDRATE   POVIDONE   POVIDONE K30   SUCRALOSE   MAGNESIUM STEARATE   PEPPERMINT   TALC   SODIUM LAURYL SULFATE   FD&C YELLOW NO. 5

Product Characteristics Color yellow (yellow) Score no score Shape ROUND (ROUND) Size 13mm Flavor PEPPERMINT (PEPPERMINT) Imprint Code AX7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24090-721-85 30 TABLET In 1 BOTTLE, PLASTIC None 2 24090-721-77 7 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA202088	12/01/2011

Labeler - Akrimax Pharmaceuticals, LLC (804790124)

Registrant - Citius Pharmaceuticals (872692764)

Establishment
Name	Address	ID/FEI	Operations
Alpex Pharma SA		481608818	manufacture

Establishment
Name	Address	ID/FEI	Operations
Siegfried (USA), Inc.		001213784	api manufacture

Revised: 10/2011Akrimax Pharmaceuticals, LLC

More Suprenza resources

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

Compare Suprenza with other medications

• Obesity
• Weight Loss

Sennalax-S

Generic Name: docusate and senna (DOK yoo sate and SEN a)

Brand Names: Doc-Q-Lax, Doculax, Dok Plus, Gentlax S, Peri-Colace, Senna Plus, Senna S, Sennalax-S, Senokot S, SenoSol-SS

What is Sennalax-S (docusate and senna)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.

Senna is a laxative. It stimulates muscle movement in the intestines.

The combination of docusate and senna is used to treat occasional constipation.

Docusate and senna may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sennalax-S (docusate and senna)?

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

You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist before using docusate and senna if you have nausea, vomiting, stomach pain, a sudden change in bowel habits, or an intestinal disorder (such as Crohn's disease or ulcerative colitis).

Do not use this medication without your doctor's advice if you are pregnant or breast-feeding. Do not take this medication for longer than 7 days in a row. Call your doctor if your constipation does not improve or if it gets worse. Stop taking this docusate and senna and call your doctor at once if you have rectal bleeding, severe stomach pain, nausea and vomiting, or if you do not have a bowel movement. Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist.

What should I discuss with my healthcare provider before using Sennalax-S (docusate and senna)?

You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist about using docusate and senna if you have:

• 
  

  nausea or vomiting;

  
  


• 
  

  stomach pain;

  
  


• 
  

  a sudden change in bowel habits that lasts for 2 weeks or longer; or

  
  


• 
  

  if you have an intestinal disorder such as Crohn's disease or ulcerative colitis.

  
  

Do not use this medication without your doctor's advice if you are pregnant. It is not known whether docusate and senna passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Ask a doctor before giving this medication to a child younger than 2 years old.

How should I use Sennalax-S (docusate and senna)?

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 medication with a full glass of water.

It may be best to take this medication at night or at bedtime. Docusate and senna should cause you to have a bowel movement within 6 to 12 hours.

Do not take this medication for longer than 7 days in a row, unless your doctor tells you to. Call your doctor if your constipation does not improve or if it gets worse after taking docusate and senna. Store docusate and senna at room temperature away from moisture and heat.

What happens if I miss a dose?

Since docusate and senna is taken as needed, you are not likely to be on a dosing schedule. If you are taking the medication regularly, 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.

Overdose symptoms may include nausea, vomiting, stomach pain, or diarrhea.

What should I avoid while using Sennalax-S (docusate and senna)?

Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist. Docusate or senna may be contained in other medicines available over the counter. If you take certain products together you may accidentally take too much of a certain medicine. Read the label of any other medicine you are using to see if it contains docusate or senna.

Sennalax-S (docusate and senna) 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 docusate and senna and call your doctor at once if you have a serious side effect such as:

• 
  

  rectal bleeding;

  
  


• 
  

  severe stomach pain, nausea, vomiting; or

  
  


• 
  

  no bowel movement.

  
  

Less serious side effects may include:

• 
  

  gas, bloating;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  mild nausea.

  
  

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 Sennalax-S (docusate and senna)?

There may be other drugs that can interact with docusate and senna. 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 Sennalax-S resources

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

• Senna Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sennalax-S with other medications

• Constipation, Acute

Where can I get more information?

• Your pharmacist can provide more information about docusate and senna.

See also: Sennalax-S side effects (in more detail)

Tirofiban

Generic Name: tirofiban (tye roe FYE ban)

Brand Names: Aggrastat

What is tirofiban?

Tirofiban keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Tirofiban is used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries).

Tirofiban may also be used for purposes other than those listed in this medication guide.

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

Do not receive this medication if you are allergic to tirofiban, or to similar drugs such as abciximab (ReoPro) or eptifibatide (Integrilin).

Do not receive this medication if you have a stomach ulcer or ulcerative colitis, severe liver disease, severe high blood pressure, a bleeding or blood clotting disorder, a history of head injury, brain tumor, or blood clot in the brain (aneurysm), a stroke or any type of bleeding within the past 30 days, or any type of surgery, injury, or medical emergency within the past 6 weeks.

Tirofiban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with tirofiban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with tirofiban and aspirin.

Because tirofiban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

What should I discuss with my health care provider before receiving tirofiban?

Do not receive this medication if you are allergic to tirofiban, or to similar drugs such as abciximab (ReoPro) or eptifibatide (Integrilin), or if you have:

• 
  

  a stomach ulcer or ulcerative colitis;

  
  


• 
  

  severe liver disease;

  
  


• 
  

  a severe form of hypertension (high blood pressure);

  
  


• 
  

  a bleeding or blood clotting disorder, such as hemophilia or thrombocytopenia;

  
  


• 
  

  a history of head injury, brain tumor, or blood clot in the brain (aneurysm);

  
  


• 
  

  if you have had a stroke or any type of bleeding within the past 30 days; or

  
  


• 
  

  if you have had any type of surgery, injury, or medical emergency within the past 6 weeks.

  
  

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

• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  stomach ulcer;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  a vision disorder involving the blood vessels in your eyes.

  
  

If you have any of these conditions, you may not be able to receive tirofiban, or you may need a dosage adjustment or special tests during treatment.

Tirofiban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with tirofiban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with tirofiban and aspirin.

It is not known whether tirofiban passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is tirofiban given?

Tirofiban is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

Tirofiban is usually given continuously for at least 2 days.

Tirofiban is sometimes given together with aspirin.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Because tirofiban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

What happens if I miss a dose?

Since tirofiban is usually given in a hospital or clinic setting as needed, it is not likely that you will miss a dose.

What happens if I overdose?

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

Symptoms of a tirofiban overdose may include vomiting, feeling exhausted or short of breath, and severe bleeding.

What should I avoid while receiving tirofiban?

While you are receiving tirofiban, do not take aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

Tirofiban lowers blood cells that help your blood clot. This can make it easier for you to bruise or bleed from an injury or minor cut. Avoid activities that increase your risk of a bruising or bleeding injury. Use extra caution to avoid cuts when brushing your teeth or shaving.

Avoid drinking alcohol while receiving tirofiban. Alcohol may increase your risk of bleeding in your stomach or intestines.

Tirofiban 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:

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  nosebleed or other bleeding that will not stop;

  
  


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  black, bloody, or tarry stools;

  
  


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  coughing up blood or vomit that looks like coffee grounds;

  
  


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  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


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  sudden numbness or weakness, especially on one side of the body;

  
  


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  sudden headache, confusion, problems with vision, speech, or balance;

  
  


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  fever, chills, body aches, flu symptoms; or

  
  


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  pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual.

  
  

Less serious side effects may also occur, such as:

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  nausea, stomach pain;

  
  


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  runny or stuffy nose, cough, sore throat; or

  
  


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  mild headache or dizziness.

  
  

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.

Tirofiban Dosing Information

Usual Adult Dose for Acute Coronary Syndrome:

Initial (IV): 0.4 mcg/kg/min for the first 30 minutes.

Maintenance (IV): 0.1 mcg/kg/min constant infusion to continue for 12 to 24 hours following angioplasty or atherectomy.

What other drugs will affect tirofiban?

Before receiving tirofiban, tell your doctor if you are using any of the following drugs:

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  phenytoin (Dilantin);

  
  


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  tamoxifen (Nolvadex);

  
  


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  tolbutamide (Orinase);

  
  


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  torsemide (Demadex);

  
  


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  fluvastatin (Lescol);

  
  


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  a blood thinner such as warfarin (Coumadin), heparin, ardeparin (Normiflo), dalteparin (Fragmin), danaparoid (Orgaran), enoxaparin (Lovenox), or tinzaparin (Innohep); or

  
  


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  any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).

  
  

If you are using any of these drugs, you may not be able to receive tirofiban, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect tirofiban. 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 tirofiban resources

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

• Tirofiban MedFacts Consumer Leaflet (Wolters Kluwer)


• Tirofiban Monograph (AHFS DI)


• Aggrastat Prescribing Information (FDA)

Compare tirofiban with other medications

• Acute Coronary Syndrome

Where can I get more information?

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

See also: tirofiban side effects (in more detail)