Acamprol Tabs.

ACAMPROL TABS. by SUN PHARMA-SEPHIUS DIV

ACAMPROL TABS. (also known as Acamprol or acAMproL Tablet) is a medication manufactured by Sun Pharmaceutical Industries Ltd., designed to assist individuals in their recovery from alcohol dependence.

• Composition: The primary active ingredient in ACAMPROL TABS. is Acamprosate Calcium, typically in a strength of 333mg.

• Uses: ACAMPROL TABS. is prescribed for the treatment of alcohol addiction. It works to reduce cravings for alcohol in individuals who have completely stopped drinking and helps in maintaining abstinence. It is most effective when used in conjunction with counseling or behavioral therapy programs. It does not treat alcohol withdrawal symptoms or prevent the harmful effects of continued alcohol abuse.

• Dosage and Administration: ACAMPROL TABS. should be taken in the dose and duration advised by a doctor. It is typically taken with food. For adults aged 18-65 years with a body weight of 60 kg or more, the recommended dose is 666 mg (two 333mg tablets) three times a day. For those weighing less than 60 kg, the recommended dosage is 666 mg at breakfast, 333 mg at midday, and 333 mg at night. The medicine is only effective once alcohol consumption has ceased completely. It should not be stopped suddenly without consulting a doctor.

• Side Effects: Common side effects may include abdominal pain, nausea, vomiting, diarrhea, decreased libido, itching, flatulence, and headache. Serious side effects, though less common, can include mood changes, new or worsening depression, suicidal thoughts or behavior, or severe allergic reactions such as angioedema or anaphylaxis. Patients experiencing persistent or concerning side effects should consult their doctor.

• Precautions: ACAMPROL TABS. should be used with caution in patients with kidney or liver disease, and dose adjustments may be necessary. It is not recommended for use in pregnant or breastfeeding women without a doctor's recommendation, nor for children under 18 years of age. Patients should inform their doctor about all current medications, including antidepressants, phenytoin, carbamazepine, tranquilizers, sleeping pills, or NSAIDs, to avoid potential drug interactions.

• Storage: Store ACAMPROL TABS. below 30°C, preferably between 15°C and 30°C. Keep the medicine in a cool, dry place, away from direct sunlight, and out of the reach of children.

ACAMPROL TABS. (Acamprosate Calcium) is a medication primarily used in the management of alcohol dependence. It works to help individuals who have already stopped drinking alcohol to maintain abstinence.

Here are some frequently asked questions about ACAMPROL TABS.:

What is ACAMPROL TABS. used for?

ACAMPROL TABS. is used to treat alcohol dependence. It helps individuals who have already achieved abstinence from alcohol to reduce cravings and maintain their sobriety. This medication is most effective when used as part of a comprehensive treatment program that includes counseling and psychosocial support. It does not prevent alcohol withdrawal symptoms or work if alcohol consumption is ongoing.

How does ACAMPROL TABS. work?

The exact mechanism of action for acamprosate is not fully understood. However, it is believed to help restore the natural balance of certain brain chemicals, such as glutamate and gamma-aminobutyric acid (GABA), which may have been altered by chronic alcohol consumption. This restoration of balance is thought to reduce alcohol cravings.

What is the usual dosage for ACAMPROL TABS.?

For most adults, the recommended dose is two 333 mg tablets (totaling 666 mg) taken three times daily. It can be taken with or without food, but taking it with meals is often suggested, especially if it causes stomach upset, and can help with adherence. For patients with moderate kidney impairment, a lower dose of one 333 mg tablet three times daily may be recommended.

What are the possible side effects of ACAMPROL TABS.?

Common side effects can include diarrhea, abdominal pain, nausea, vomiting, flatulence, headache, back pain, decreased sexual desire (libido), impotence, itching, skin rash, and sleep disturbances. More serious, though less common, side effects may involve mental/mood changes, severe depression, suicidal thoughts or actions, fainting, or severe allergic reactions. Any mood changes or suicidal thoughts should be reported to a doctor immediately.

Is ACAMPROL TABS. safe during pregnancy or breastfeeding?

ACAMPROL TABS. is generally not recommended during pregnancy or breastfeeding. If considering use during pregnancy, the potential benefits must clearly outweigh the potential risks to the fetus. For breastfeeding mothers, it is unknown if the drug passes into breast milk, and caution is advised.

Can ACAMPROL TABS. be taken with other medications?

It is important to inform your doctor about all prescription, over-the-counter medications, vitamins, minerals, and herbal products you are taking. No clinically significant interactions have been observed with alcohol, diazepam, or disulfiram. While naltrexone may increase acamprosate levels, typically no dosage adjustment is needed. Since acamprosate is not metabolized by the liver, it can be a suitable option for individuals with liver disease.

What precautions should be taken while using ACAMPROL TABS.?

This medication should only be used after you have completely stopped drinking alcohol and as part of a comprehensive treatment plan that includes counseling and support. Use with caution if you have kidney disease, as dosage adjustments may be necessary, and it is contraindicated in severe kidney impairment. Be aware that it may affect coordination, reaction time, or judgment, so avoid driving or operating machinery if you experience dizziness or drowsiness.

What happens if a dose of ACAMPROL TABS. is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ACAMPROL TABS. be stored?

Store ACAMPROL TABS. at room temperature, typically around 25°C (77°F), with permitted excursions between 15° to 30°C (59° to 86°F). Keep the medication in its original container, tightly closed, and protect it from excess heat and moisture. It should always be kept out of the sight and reach of children.