Adpine

Description

Adpine Tablet

Generic Name: Cyproheptadine HCl

Manufacturer: Lomus Pharmaceutical Pvt. Ltd.

Availability: Available in Nepal

Indications

Adpine Tablet is used for various conditions, including:

• Allergic Conditions: Relief of rash and pruritus (itching) associated with various allergic reactions.
• Appetite Stimulation: To stimulate appetite, particularly in cases of anorexia nervosa.
• Endocrine Disorders: Management of Cushing’s syndrome, Nelson’s syndrome, acromegaly, and hyperprolactinemia.
• Migraine: Treatment and prophylaxis of migraine and other vascular headaches.
• Antidepressant-Induced Anorgasmia: To address anorgasmia (inability to achieve orgasm) caused by antidepressant medications.

Dosage and Administration

Adult Dosing

1. Allergic Conditions (Oral)

• Initial Dose: 4 mg three times a day (TID).
• Adjustment: Adjust as necessary based on response.
• Usual Dose: 12-16 mg daily, divided into 3-4 doses.
• Maximum Dose: 32 mg per day.

2. Treatment and Prophylaxis of Migraine and Other Vascular Headaches (Oral)

• Acute Treatment: 4 mg, which may be repeated after 30 minutes.
• Maximum: Do not exceed 8 mg within a 4- to 6-hour period.
• Maintenance: 4 mg every 4-6 hours.

Child Dosing (Oral)

1. Allergic Conditions

• Children 2-6 years: 2 mg once or twice a day (BID) or three times a day (TID).
• Maximum (2-6 years): 12 mg per day.
• Children 7-14 years: 4 mg once or twice a day (BID) or three times a day (TID).
• Maximum (7-14 years): 16 mg per day.

2. Migraine Prophylaxis

• Children < 3 years: Safety and efficacy have not been established.
• Children > 3 years and Adolescents: 0.2-0.4 mg/kg/day orally, divided into two doses (BID).
• Maximum: Do not exceed 0.5 mg/kg/day.

Administration Tips

• Adpine Tablet can be taken with or without food.
• Taking it with meals may help reduce any gastrointestinal discomfort.

Contraindications

Do not use Adpine Tablet if you have:

• Narrow-angle glaucoma.
• An acute asthmatic attack.
• Bladder neck obstruction.
• Stenosing peptic ulcer.
• Gastrointestinal tract (GIT) obstruction.
• Are currently undergoing MAOI (monoamine oxidase inhibitor) therapy.
• Known hypersensitivity to cyproheptadine or any of its components.
• Are a neonate.
• Are lactating (breastfeeding).

Precautions

Use Adpine Tablet with caution in:

• Elderly patients.
• Individuals with epilepsy.
• Patients performing tasks requiring mental alertness (e.g., driving, operating machinery) due to potential for drowsiness.
• Individuals with symptomatic prostate hypertrophy.
• Patients with alcoholism.
• Pregnant women.

Specific Considerations:

• Lactation: Excretion into breast milk is unknown, but it is contraindicated in breastfeeding mothers.
• Pregnancy: Use with caution.

Interactions

• CNS Depressants: May have additive sedative effects when used with other central nervous system (CNS) depressants such as hypnotics, sedatives, tranquilizers, and anti-anxiety agents.
• Potentially Fatal Interaction:
  • MAOIs (Monoamine Oxidase Inhibitors): MAOIs can prolong and intensify the anticholinergic effects of antihistamines like cyproheptadine, potentially leading to severe adverse reactions. Concomitant use is contraindicated.

Adverse Effects

Side effects of Cyproheptadine HCl can vary in frequency and severity. They commonly affect the central nervous system but can impact other body systems.

Common Side Effects (Psychiatric/Neurologic):

• CNS Depression: Drowsiness, sedation (ranging from mild drowsiness to deep sleep – most frequent).
• Dizziness.
• Lassitude (lack of energy).
• Disturbed coordination.
• Less commonly: Restlessness, insomnia, tremors, euphoria, nervousness, irritability, delirium, seizures, toxic psychosis, paresthesia (tingling or numbness).

Other Potential Side Effects:

• Muscular: Weakness.
• Cardiovascular: Palpitation, tachycardia, ECG changes (e.g., widened QRS), arrhythmias (e.g., extrasystole, heart block), hypotension, hypertension, sedation (cardiovascular).
• Gastrointestinal (GI): Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
• Hepatic (Liver): Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice (rare).
• Skin: Eczema, pruritus, inflammation, papular rash, erythema on exposed skin.
• Sensory: Visual disturbances, blurred vision, diplopia (double vision), tinnitus (ringing in ears), acute labyrinthitis (inner ear inflammation).
• Renal (Kidney): Dysuria (painful urination), urinary retention.
• Respiratory: Thickening of bronchial secretions, wheezing, nasal stuffiness.
• Other: Vertigo, sweating, chills, early menses, headache, impotence, dryness of mouth, nose, and throat, facial dyskinesia (involuntary movements), tightness of chest, faintness.

Mechanism of Action

Cyproheptadine is a sedating antihistamine that works by competing with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. It also possesses antimuscarinic, serotonin antagonist, and calcium channel blocking properties, contributing to its diverse therapeutic and side effects.