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ALZOCUM® Alprazolam Tablets, USP

ALZOCUM ® ALPRAZOLAM TABLETS, USP 0.25 mg, 0.5 mg and 1 mg
CIV
Each uncoated tablet contains: Alprazolam USP. 0.25 mg, Excipients Q.S.
Each uncoated tablet contains: Alprazolam USP. 0. 50 mg, Excipients Q.S.
Each uncoated tablet contains: Alprazolam USP. 1.00 mg, Excipients Q.S.
Colors : Erythrosine                                     
Managing an anxiety disorder can be difficult

Support for navigating the challenges of living with this condition

ALZOCUM (alprazolam) is indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety in adults. ALZOCUM is also indicated for the treatment of panic disorder in adults, with or without agoraphobia.

IMPORTANT SAFETY INFORMATION ABOUT ALZOCUM
Do not take ALZOCUM if you are allergic to alprazolam or other benzodiazepines.

Do not take ALZOCUM if you currently take ketoconazole or itraconazole (antifungal treatments) or if you have acute narrow angle glaucoma. Before taking ALZOCUM, tell your healthcare professional about any alcohol consumption and all prescription, over-the-counter medications and supplements you take, because some medications can increase the concentration of ALZOCUM in your bloodstream. Alcohol should generally not be used during treatment with benzodiazepines such as ALZOCUM.

Tell your healthcare professional if you are pregnant, if you are nursing, if you are planning to have a child, or if you become pregnant while you are taking this medication.

Until you see how ALZOCUM affects you, do not drive a car or operate potentially dangerous machinery.

Do not increase the dose of ALZOCUM, even if you think it isn’t working, without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence.

Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur.

INDICATION
ALZOCUM (alprazolam) is indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety in adults. ALZOCUM is also indicated for the treatment of panic disorder in adults, with or without agoraphobia.

  WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.

How to use ALZOCUM
Take this medication by mouth as directed by your doctor. Dosage is based on your medical condition, age, and response to treatment. Your dose may be gradually increased until the drug starts working well. Follow your doctor's instructions closely to reduce the risk of side effects.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens.
Side Effects
Drowsiness, dizziness, increased saliva production, or change in sex drive/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as hallucinations, thoughts of suicide), slurred speech or difficulty talking, loss of coordination, trouble walking, memory problems.Get medical help right away if these rare but very serious side effects occur: yellowing eyes or skin, seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions: Before taking alprazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe lung/breathing problems (such as COPD, sleep apnea), liver disease, kidney disease, drug or alcohol abuse, glaucoma.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness. These side effects can increase the risk of falling. Alprazolam is not recommended for use during pregnancy due to the potential for harm to an unborn baby. Consult your doctor for more details.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

What should I know regarding pregnancy, nursing and administering ALZOCUM to children or the elderly?
Interactions : Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: kava, sodium oxybate.

Other medications can affect the removal of alprazolam from your body, which may affect how alprazolam works. Examples include azole antifungals (such as itraconazole, ketoconazole), cimetidine, certain anti-depressants (such as fluoxetine, fluvoxamine, nefazodone), drugs to treat HIV (delavirdine, protease inhibitors such as indinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (such as diphenhydramine), medicine for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients which cause drowsiness. Ask your pharmacist about the safe use of those products.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.
Does ALZOCUM interact with other medications?

Should I avoid certain foods while taking ALZOCUM?

Notes : Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose : If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE : Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

DO NOT FLUSH MEDICATIONS DOWN THE TOILET OR POUR THEM INTO A DRAIN UNLESS INSTRUCTED TO DO SO. PROPERLY DISCARD THIS PRODUCT WHEN IT IS EXPIRED OR NO LONGER NEEDED. CONSULT YOUR PHARMACIST OR LOCAL WASTE DISPOSAL COMPANY FOR MORE DETAILS.


Contraindications
Alzocum Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alzocum may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.Alzocum-Alprazolam-IP-1mg

Alzocum is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see WARNINGS and PRECAUTIONS-DRUG INTERACTIONS).

Presentation
Alzocum  0.25               Blister pack of 10 tablets
Alzocum  0.50               Blister pack of 10 tablets
Alzocum  1.00               Blister pack of 10 tablets

 

Alzocum-Tablets_small Alzocum-Alprazolam-Tablets-IP_small



Note :
This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

 

 

 


 

 

 

 


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SCHEDULE IV CONTROLLED SUBSTANCES : Controlled Substances Import and Export Act
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
"Placement on schedules; findings required Schedule IV substances are those that have the following findings:The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. The drug or other substance has a currently accepted medical use in treatment in the United StatesAbuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.Control measures are similar to Schedule III. Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in. DRUGS IN THIS SCHEDULE INCLUDE:Benzodiazepines, such as ALPRAZOLAM (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Valium), and Lorazepam (Ativan), as well as:temazepam (Restoril) (note that some states require specially coded prescriptions for temazepam) flunitrazepam (Rohypnol) (note that flunitrazepam is not used medically in the United States). The benzodiazepine-like Z-drugs: zolpidem (Ambien), zopiclone (Imovane), eszopiclone (Lunesta), and zaleplon (Sonata) (zopiclone is not commercially available in the U.S.) Chloral hydrate, a sedative-hypnotic, Long-acting barbiturates such as phenobarbitalSome partial agonist opioid analgesics, such as pentazocine (Talwin) The stimulant-like drug modafinil (sold in the U.S. as Provigil) as well as its (R)-enantiomer armodafinil (sold in the U.S. as Nuvigil)
Difenoxin, an antidiarrheal drug, such as when combined with atropine (Motofen) (difenoxin is 2–3 times more potent than diphenoxylate, the active ingredient in Lomotil, which is in Schedule V)
Tramadol (Ultram) / Carisoprodol (Soma) has become a Schedule IV medication as of 11 January 2012.
Section 1000 [951 note] Short Title
This title may be cited as the "Controlled Substances Import and Export Act.'' EXPORT IS SUBJECTED TO NOC (Narcotic Drugs Import and Export Act) INDIA.
Export/ Import
ANY NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES CAN BE IMPORTED INTO/ EXPORTED OUT OF INDIA SUBJECT TO RULE 53 AND RULE 53-A OF THE NDPS RULES, 1985.
The import of - (i) opium, concentrate of poppy straw, and (ii) morphine, codeine, thebaine, and their salts is prohibited save by the Government Opium Factory under the provision of Rule 54 of the NDPS Rules, 1985. The import into and export out of India of any narcotic drugs or psychotropic substances specified in Schedule I  is prohibited under the provision of Rule 53 of the NDPS Rules, 1985. The export of any narcotic drugs or psychotropic substances or preparations containing any of such narcotic drugs or psychotropic substances specified in Schedule II  shall be prohibited to the countries or to the region of such country specified therein under the provision of Rule 53-A of the NDPS Rules, 1985.The manufacture of psychotropic substances specified in Schedule III  can be allowed for export purpose only under the provision of Rule 65(1) of the NDPS Rules, 1985. The import of psychotropic substances specified in Schedule III may be allowed for test/ analysis purpose as well as for re-export purpose. The export out of / import into India of a select number of Precursor Chemicals  is exercised by the Narcotics Commissioner in accordance with Directorate General of Foreign Trade (DGFT) notification  and Administrative Control.
ANY COMPANY/APPLICANT DESIROUS OF OBTAINING NO OBJECTION CERTIFICATE FOR EXPORT OF NOTIFIED PRECURSOR CHEMICALS ARE  REQUIRED TO APPLY TO THE NARCOTICS COMMISSIONER. (UNDER RULES FROM CENTRAL BUREAU OF NARCOTICS, GOVERNMENT OF INDIA)

 

   
   

 

 

 

 

 

 


 

 

 

 

 

 

 

 

 

 














 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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