Amixide-H

Description

“Amixide-H” is a brand name for a combination medication containing two active ingredients:

1. Amitriptyline: A tricyclic antidepressant (TCA).
2. Chlordiazepoxide: A benzodiazepine (anxiolytic/sedative).

This combination is primarily used to treat moderate to severe depression associated with anxiety.

In Nepal, “Amixide-H” is a commonly available brand, often manufactured by Sun Pharmaceutical Industries Ltd. (India), but similar combinations exist from other manufacturers. The strengths commonly found are Amitriptyline 12.5mg + Chlordiazepoxide 5mg, or Amitriptyline 25mg + Chlordiazepoxide 5mg.

Product Overview

Active Ingredients:

• Amitriptyline: A tricyclic antidepressant that works by increasing the levels of certain chemical messengers in the brain, such as serotonin and norepinephrine. These neurotransmitters help regulate mood and alleviate symptoms of depression.
• Chlordiazepoxide: A benzodiazepine that works by enhancing the action of GABA (gamma-aminobutyric acid), a natural calming neurotransmitter in the brain. This helps to suppress excessive and abnormal nerve cell activity, leading to a calming effect that reduces anxiety, tension, and promotes sleep.

Mechanism of Action (Combined): The combination provides a dual action:

• Antidepressant effect: Primarily from Amitriptyline, addressing the underlying depressive symptoms.
• Anxiolytic and Sedative effect: Primarily from Chlordiazepoxide, providing immediate relief from anxiety, tension, agitation, and insomnia often associated with depression.

Key Uses: Amixide-H is specifically used for the treatment of:

• Moderate to severe depression associated with moderate to severe anxiety.
• It helps to improve mood, reduce feelings of tension and worry, and can aid in better sleep.

Side Effects

Due to the combination of two active drugs, Amixide-H has a broad range of potential side effects, some of which are common to TCAs and some to benzodiazepines.

Common Side Effects:

• Drowsiness/Sedation: Very common due to both components, especially chlordiazepoxide.
• Dry Mouth (Anticholinergic effect)
• Constipation (Anticholinergic effect)
• Blurred Vision (Anticholinergic effect)
• Difficulty in urination (Anticholinergic effect)
• Dizziness/Lightheadedness: Especially when standing up too quickly (orthostatic hypotension), due to amitriptyline.
• Weight gain: Common with amitriptyline.
• Increased heart rate (tachycardia)
• Confusion (especially in elderly patients)
• Uncoordinated body movements (ataxia)
• Tiredness
• Memory impairment
• Nausea, vomiting, indigestion
• Sexual dysfunction (decreased libido, erectile dysfunction, difficulty reaching orgasm)

Less Common / Potentially More Serious Side Effects (seek medical attention if experienced):

• Suicidal Thoughts or Behavior: Especially at the beginning of treatment or with dose changes, particularly in young adults (under 25).
• Cardiac Problems: Irregular heartbeat (arrhythmias), chest pain, heart attack (rare but serious, especially in patients with pre-existing heart conditions).
• Seizures (Fits): Risk is generally low but can occur.
• Severe Allergic Reactions/Skin Rashes: Hives, swelling of face/tongue/throat, difficulty breathing, severe widespread rash.
• Liver Problems: Symptoms like yellowing of skin/eyes (jaundice), dark urine, persistent nausea/vomiting, severe stomach pain.
• Blood Dyscrasias: Rare but serious, affecting blood cell counts (e.g., agranulocytosis, requiring immediate medical attention if fever, sore throat, or other infection signs appear).
• Paradoxical Reactions: Increased anxiety, agitation, aggression, or insomnia (more common with benzodiazepines).
• Angle-closure Glaucoma: Can worsen or precipitate in susceptible individuals.

Precautions

Amixide-H is a potent medication and requires strict medical supervision and adherence to prescription.

1. Do NOT Stop Abruptly: Both amitriptyline and chlordiazepoxide can cause withdrawal symptoms if stopped suddenly. Amitriptyline withdrawal can cause flu-like symptoms, irritability, and sleep disturbances. Chlordiazepoxide (a benzodiazepine) can cause severe withdrawal including seizures, rebound anxiety, and insomnia. Your doctor will provide a gradual tapering schedule when discontinuing.
2. Addiction/Dependence: Chlordiazepoxide carries a risk of psychological and physical dependence, especially with prolonged use or at higher doses. Use for the shortest duration necessary.
3. Suicidal Thoughts: Close monitoring for worsening depression, suicidal thoughts, or unusual changes in behavior is crucial, especially during the initial weeks of treatment.
4. Alcohol and Other CNS Depressants: ABSOLUTELY AVOID ALCOHOL and other CNS depressants (e.g., opioids, other sedatives, antihistamines) while taking Amixide-H, as this can lead to severe sedation, respiratory depression, coma, or even death.
5. Drug Interactions: Inform your doctor about ALL medications (prescription, over-the-counter), herbal products, and supplements you are taking. Critical interactions include:
   • MAO Inhibitors (MAOIs): Amixide-H is contraindicated with MAOIs (e.g., phenelzine, tranylcypromine, selegiline, moclobemide, linezolid, methylene blue). A washout period of at least 14 days is required between stopping an MAOI and starting Amixide-H, and vice versa, due to the risk of severe, life-threatening reactions (hypertensive crisis, serotonin syndrome).
   • Other Antidepressants (SSRIs, SNRIs): Increased risk of serotonin syndrome.
   • Opioid Pain Relievers: Increased risk of severe sedation, respiratory depression, coma, and death. Concomitant use should be avoided or done with extreme caution under close monitoring.
   • Anticholinergic Drugs: Increased risk of side effects like dry mouth, constipation, urinary retention, blurred vision.
   • Cimetidine, Fluoxetine: Can increase amitriptyline levels.
   • Barbiturates, Carbamazepine, Rifampicin: Can decrease amitriptyline levels.
   • Anticoagulants (Warfarin): May alter their effect.
   • Antihypertensives: May cause a drop in blood pressure.
6. Medical Conditions: Inform your doctor about your full medical history, especially if you have:
   • Severe liver disease
   • Severe breathing difficulties (including sleep apnea)
   • Myasthenia gravis (muscle weakness)
   • Glaucoma (especially narrow-angle glaucoma)
   • Urinary retention or prostate enlargement
   • Heart disease (recent heart attack, arrhythmias, heart failure)
   • Epilepsy or history of seizures
   • Diabetes (monitor blood glucose regularly)
   • Thyroid problems (overactive thyroid)
   • Bipolar disorder (can induce mania)
   • Kidney disease
   • History of drug or alcohol abuse (due to dependence potential of chlordiazepoxide)
7. Children and Adolescents: Amixide-H is generally not recommended for use in children and adolescents below 18 years of age due to increased risks including suicidal thoughts and behavior, and lack of established efficacy.
8. Elderly Patients: Use with caution in older patients (typically 65 years or older) due to increased sensitivity to side effects like drowsiness, dizziness, confusion, and cardiovascular effects. Lower doses are usually recommended.
9. Driving/Operating Machinery: Due to its sedative effects and potential for impaired concentration and motor skills, do not drive or operate heavy machinery until you know how the medication affects you.
10. Pregnancy and Breastfeeding: Not recommended during pregnancy due to definite risks to the fetus (e.g., withdrawal symptoms in the newborn). It is also unsafe during breastfeeding as it can pass into breast milk. Discuss alternatives with your doctor.
11. Regular Monitoring: Long-term use may require regular monitoring of blood counts and liver function.

Prescription Information

• Availability: Amixide-H is a prescription-only medication in Nepal and globally. It must be used under the direct supervision of a qualified healthcare professional.
• Dosage: The dosage is highly individualized and determined by the doctor based on the patient’s condition, severity, and response. It is often started at a lower dose and gradually increased.
  • Typical strengths: Amitriptyline 12.5mg + Chlordiazepoxide 5mg, or Amitriptyline 25mg + Chlordiazepoxide 5mg.
  • Administration: Take the tablet orally, with or without food. It is advised to take it at a fixed time each day to maintain consistent blood levels. Often taken at night due to sedative effects. Do not chew, crush, or break the tablet.
• Consistency: Take the medication regularly as prescribed. Do not stop treatment suddenly, even if you feel better.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take a double dose.
• Storage: Store at room temperature, away from moisture, heat, and direct light. Keep out of reach of children. Do not use after the expiry date