Cyproheptadine Tablets

Description

Cyproheptadine Tablets (4mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Cyproheptadine Hydrochloride Tablets in India. Cyproheptadine is a first-generation H1 antihistamine with antiserotonergic and anticholinergic activity. Its established uses include relief of selected allergic conditions such as urticaria and pruritus. Other uses, including appetite stimulation or migraine-related treatment, vary by country and should follow local approved labeling and clinical guidance.

2. Product Specifications

3. Manufacturing Technology

• Taste Masking: Sugar- or film-coated presentations can be manufactured where included in the registered formulation to improve palatability.
• Content Uniformity: Validated blending and compression processes support consistent low-dose active distribution across dosage units.
• Coating Control: Coating weight, appearance and performance are controlled according to approved specifications.
• Other Dosage Forms: Syrup or other presentations require separate formulation, stability and registration documentation.

4. Quality Assurance

• Dissolution: Tested according to the applicable pharmacopoeial or registered finished-product specification.
• Assay & Uniformity: Potency and dosage-unit uniformity are verified against approved limits.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.

5. Pharmacology and Clinical Use

Cyproheptadine blocks histamine H1 receptors and also has serotonin-antagonist and anticholinergic effects.

• Allergic Conditions: May relieve itching, urticaria and other allergic symptoms included in the approved product label.
• Cold Urticaria: Antihistamine therapy may be used for selected patients under appropriate clinical guidance.
• Appetite Stimulation: Cyproheptadine can increase appetite in some patients, but it should not be promoted as a routine weight-gain medicine for healthy people; use should be medically appropriate and consistent with local labeling.
• Other Uses: Migraine or other off-label uses require clinician assessment and should not be assumed to be approved in every market.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to destination-market requirements.

7. Frequently Asked Questions

Q: Who manufactures Cyproheptadine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Cyproheptadine tablet formulations in India.

Q: Is Cyproheptadine sold under different brands?
A: Yes. Cyproheptadine is marketed under multiple brand names. Generic equivalence or interchangeability should only be claimed where supported by the specific product's regulatory approval.

Q: Can Cyproheptadine increase appetite?
A: Increased appetite and weight gain can occur, but suitability depends on the patient and indication. Unexplained weight loss or poor appetite should be medically assessed rather than treated routinely with an appetite stimulant.

Q: Can it cause sleepiness?
A: Yes. Drowsiness, dizziness and reduced alertness are common with first-generation antihistamines and can impair driving or operating machinery.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dosage depends on age, indication, response, local labeling and individual risk factors. Follow the registered prescribing information or clinician's directions.
• Pediatrics: Pediatric dosing requires age-appropriate prescribing. Cyproheptadine should not be used in children below the minimum age specified by the local product label.
• Administration: Take only as directed. Food instructions depend on the specific product and patient tolerance.

9. Side Effects and Precautions

• CNS: Drowsiness, dizziness, impaired coordination and reduced alertness may occur. Avoid driving or hazardous tasks until the effect is known.
• Anticholinergic Effects: Dry mouth, blurred vision, constipation and urinary difficulty/retention can occur.
• Alcohol & Sedatives: Alcohol and other CNS depressants can increase sedation.
• Glaucoma / Urinary Retention: Use may be inappropriate in certain patients with angle-closure glaucoma, bladder-neck obstruction or significant urinary retention; follow contraindications and clinician advice.
• MAO Inhibitors: Concomitant MAOI use can intensify or prolong anticholinergic effects and may be contraindicated according to product labeling.
• Young Children: First-generation antihistamines can cause serious adverse effects in very young children; use only within approved age limits and under appropriate medical guidance.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Keep in a dry place and protect from excessive moisture.
• Keep container tightly closed or tablets in original blister packaging.
• Keep out of reach of children.