Naltima 50 Tab

NALTIMA 50 TAB by INTAS PHARMACEUTICALS LTD

Name

Common Name: Naltima 50 Tablet Brand Name: NALTIMA 50 TAB

Composition

NALTIMA 50 TAB contains 50 mg of Naltrexone as its active ingredient. Naltrexone is classified as an opioid antagonist.

Uses

NALTIMA 50 TAB is primarily prescribed as part of a comprehensive management program, including counseling and social support, for the treatment of:

• Alcohol Dependence: It helps to reduce cravings and urges to use alcohol, assisting patients in abstaining from drinking alcoholic beverages.
• Opioid Dependence and Addiction: It works by blocking the euphoric and sedative effects of opioids, thereby decreasing cravings and preventing relapse in individuals dependent on opioids.

Dosage and Administration

• The typical starting dosage for adults is 50 mg once daily. The doctor may adjust the dose based on individual response and needs, with a maximum recommended dose of 100 mg per day.
• NALTIMA 50 TAB should be taken regularly at a fixed time each day as prescribed by a doctor to achieve maximum benefit.
• It can be taken with or without food, though taking it with food may help to reduce stomach upset.
• Swallow the tablet whole with a glass of water; do not crush, chew, or break it.
• Do not discontinue the medication abruptly without consulting a doctor, as it may lead to a clinical worsening of the condition or withdrawal symptoms.

Side Effects

Common Side Effects:

• Nausea, vomiting, abdominal pain, diarrhea, constipation
• Headache, dizziness, sleeplessness/insomnia, restlessness, nervousness, anxiety, weakness, unusual tiredness
• Joint pain, muscle pain
• Decreased appetite, increased thirst, increased tear secretion/sweating
• Heart palpitations, increased heart rate, libido disorders, delayed ejaculation, erectile dysfunction

Serious Side Effects (Consult a doctor immediately if experienced):

• Depression, suicidal thoughts, or hallucinations
• Signs of liver damage such as dark urine, yellowing of the skin or eyes, unusual bleeding or bruising, severe abdominal pain, nausea, vomiting, or fever.

Precautions

• Contraindications: NALTIMA 50 TAB is contraindicated in patients with current physiologic opioid dependence, acute opioid withdrawal, or a positive urine screen for opioids. It should not be used by individuals who have failed a naloxone challenge test. It is also not recommended for those with severe hepatic impairment, acute hepatitis, severe renal impairment, suicidal thoughts, or known allergy to Naltrexone. It is generally not recommended for children and adolescents under 18 years of age, or pregnant and breastfeeding women.
• Liver and Kidney Disease: Use with caution in patients with liver or kidney disease. Regular monitoring of liver and kidney function tests is advisable during treatment.
• Alcohol Consumption: Consumption of alcohol is not recommended during treatment due to an increased risk of liver damage and interference with the medication's effectiveness.
• Opioid Use: Patients must not have used any other opiates for at least 7 to 10 days before initiating Naltrexone treatment. Concomitant use with high-dose opioids can lead to life-threatening opioid poisoning.
• Driving and Machinery: NALTIMA 50 TAB may cause dizziness and sedation, affecting the ability to drive or operate machinery. Patients should avoid such activities until they know how the medicine affects them.
• Medical History: Inform the doctor about all medical conditions (especially hepatitis or liver failure), allergic reactions, and all medications being taken (especially opioid analgesics) before starting treatment.
• Mood Changes: If mood changes are noticed while taking this medicine, consult a doctor immediately.

Storage

• Store NALTIMA 50 TAB at room temperature, typically between 20°C to 25°C.
• Keep it away from heat, moisture, and direct light.
• Do not freeze the tablets unless otherwise directed by the package instructions.
• Avoid storing in humid places like bathrooms.
• Keep the medicine out of reach of children and pets.
• The shelf life of Naltima 50mg tablets is generally 2 years.

Here are frequently asked questions about NALTIMA 50 TAB by INTAS PHARMACEUTICALS LTD:

What is NALTIMA 50 TAB used for?

NALTIMA 50 TAB is primarily used to treat alcohol dependence (chronic alcoholism) and opioid dependence or addiction. It is used as part of a comprehensive management program that includes counseling and social support to help patients abstain from alcohol and opioids.

How does NALTIMA 50 TAB work?

NALTIMA 50 TAB contains Naltrexone, an opioid antagonist. It works by blocking opioid receptors in the brain. This action decreases cravings and urges to use alcohol or opioids and prevents the euphoric feelings (highs) that some people experience after consuming these substances.

What is the usual dosage of NALTIMA 50 TAB?

For most patients, the recommended dose is 50 mg once daily. For opioid dependence, treatment may start with a lower dose (e.g., 25 mg), which can be increased to 50 mg daily if no withdrawal signs occur. It should be taken exactly as prescribed by your doctor. NALTIMA 50 TAB can be taken with or without food, though taking it with food may help reduce stomach upset.

What are the possible side effects of NALTIMA 50 TAB?

Common side effects can include nausea, vomiting, headache, nervousness, anxiety, sleep disorders (such as insomnia or drowsiness), restlessness, abdominal pain, joint pain, muscle pain, weakness, and dizziness. Not everyone experiences these side effects, and they are often temporary. If any side effects persist or cause serious discomfort, consult your doctor.

Is NALTIMA 50 TAB safe during pregnancy or breastfeeding?

NALTIMA 50 TAB is generally not recommended during pregnancy unless absolutely necessary, as limited human data and animal studies have shown potential adverse effects on the developing baby. Similarly, it is probably unsafe to use during breastfeeding, as the drug may pass into breast milk and potentially harm the baby. It is crucial to discuss the risks and benefits with your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can NALTIMA 50 TAB be taken with other medications?

NALTIMA 50 TAB should not be taken with opioid analgesics (pain relievers containing opioids) as it blocks their effects and can precipitate withdrawal symptoms in individuals physically dependent on opioids. Taking opioids to overcome Naltrexone's blockade can lead to overdose, coma, or death. Inform your doctor about all medications, herbal products, and supplements you are taking, especially medicines for cough (e.g., dextromethorphan), diarrhea (e.g., loperamide), or pain (e.g., codeine, tramadol), as interactions can occur.

What precautions should be taken while using NALTIMA 50 TAB?

Before taking NALTIMA 50 TAB, inform your doctor about all your medical conditions, particularly hepatitis or liver failure, and any allergic reactions. This medicine is contraindicated in patients with current physiological opioid dependence, acute opioid withdrawal, or a positive urine screen for opioids. Use with caution in patients with liver or kidney disease, and regular monitoring of liver function tests may be required. As it can cause dizziness and sedation, avoid driving or operating heavy machinery until you understand how the medication affects you. Do not consume alcohol during treatment, as it can increase the severity of side effects and worsen your condition. Do not stop taking the medicine suddenly without consulting your doctor.

What happens if a dose of NALTIMA 50 TAB 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 NALTIMA 50 TAB be stored?

NALTIMA 50 TAB should be stored at room temperature, generally below 30°C (or between 20-25°C), in a cool and dry place. Keep it away from heat, direct light, and moisture. Ensure it is kept out of the reach of children and pets. Do not freeze the tablets.