Gravibinan Injection 250mg/5mg (Diphenhydramine + Dihydroergotamine) — 1mL Ampoule

Description

Gravibinan is a combination injection used primarily for the treatment of acute migraine attacks. It contains Dihydroergotamine mesylate (5mg), a vasoconstrictor acting on cranial blood vessels, and Diphenhydramine HCl (250mg), an antihistamine with antiemetic and sedative properties. This combination helps in controlling severe migraine pain and associated nausea or vomiting.

Ingredients

• Active ingredients:

  • Dihydroergotamine mesylate 5 mg

  • Diphenhydramine hydrochloride 250 mg

• Excipients: sterile solvent, stabilizers, and preservatives (as per manufacturer)

Drug Class

• Dihydroergotamine: Ergot alkaloid (antimigraine vasoconstrictor)

• Diphenhydramine: Antihistamine (H1-receptor antagonist, antiemetic, sedative)

Dosage Form

• Sterile solution in 1 mL ampoule for intramuscular (IM) or slow intravenous (IV) injection

Uses / Indications

• Acute treatment of severe migraine attacks, especially with associated nausea and vomiting

• Relief of vascular headaches when conventional oral therapy is ineffective

• Supportive therapy in status migrainosus (refractory migraine) under hospital setting

Dosage

• Adult: Dose determined by physician; typically given as 1 ampoule IM/IV, with a maximum limit set to avoid ergot toxicity.

• Frequency: May be repeated if needed, but not to exceed manufacturer-recommended daily and weekly limits.

• Important: Should be administered under supervision of a qualified healthcare professional.

In Case of Overdose

• Symptoms: Severe vasospasm, hypertension, ischemia, numbness/tingling, confusion, hallucinations, drowsiness, convulsions.

• Management: Discontinue drug, supportive care, maintain hydration, vasodilators or symptomatic therapy under medical supervision.

Missed Dose

• Since it is given as needed for acute migraine, there is usually no strict schedule.

• Do not double dose — take only under medical advice when the next migraine occurs.

How To Use / Administration Instructions

1. Inspect the ampoule for clarity and integrity.

2. Administer via intramuscular injection or slow IV injection by healthcare personnel.

3. Do not self-administer unless trained.

4. Follow dosing limits to avoid ergotism (vasospasm from ergot alkaloids).

When Not to Use / Contraindications

• Hypersensitivity to ergot alkaloids or diphenhydramine

• Pregnancy and breastfeeding (ergot alkaloids can cause uterine contraction and reduce milk production)

• Patients with hypertension, coronary artery disease, peripheral vascular disease, severe liver or kidney disease

• Concomitant use with CYP3A4 inhibitors (e.g. macrolides, azole antifungals, protease inhibitors) due to risk of ergot toxicity

• Children, unless prescribed by a physician

Side Effects / Adverse Reactions

Common:

• Nausea, vomiting, dizziness

• Drowsiness, dry mouth, blurred vision (from diphenhydramine)

Serious:

• Vasospasm → cold extremities, numbness, tingling

• Hypertension, arrhythmias, chest pain

• Allergic reaction (rash, swelling, difficulty breathing)

• Severe ischemia (rare but life-threatening)

Precautions & Warnings

• Use under medical supervision only

• Avoid in cardiovascular disease or uncontrolled hypertension

• Limit frequency of use to prevent ergotism (toxicity from cumulative ergot alkaloids)

• Avoid alcohol and CNS depressants (additive sedation with diphenhydramine)

• Elderly patients may be more sensitive to antihistamine side effects

Drug Interactions

• CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, ritonavir): ↑ risk of severe vasospasm/ischemia

• Other vasoconstrictors (e.g. triptans, ergot derivatives): additive risk of vascular adverse effects

• CNS depressants (benzodiazepines, alcohol, opioids): ↑ sedation from diphenhydramine

• Antihypertensives: effects may be antagonized by vasoconstrictor component

Storage / Disposal

• Store below 25°C in a cool, dry place, away from direct light

• Do not freeze

• Discard unused ampoules properly; dispose of needles/syringes in sharps container

Control Drug / Prescription Status

• Prescription-only medicine

• Use restricted to medical supervision due to ergot alkaloid risks

Quick Tips

• Gravibinan is reserved for acute migraine attacks not responding to oral therapy.

• Do not exceed prescribed dose or frequency — risk of dangerous vascular side effects.

• Report immediately if you experience chest pain, cold/numb extremities, or severe dizziness.

• Avoid during pregnancy and lactation.