MAXALT-MLT- rizatriptan benzoate tablet, orally disintegrating MAXALT- rizatriptan benzoate tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

RIZATRIPTAN BENZOATE (UNII: WR978S7QHH) (RIZATRIPTAN - UNII:51086HBW8G)

Sẵn có từ:

STAT RX USA LLC

INN (Tên quốc tế):

RIZATRIPTAN BENZOATE

Thành phần:

RIZATRIPTAN BENZOATE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults. MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population. MAXALT should not be given to patients with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease (see WARNINGS). Because MAXALT may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS). MAXALT should not be used within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type

Tóm tắt sản phẩm:

No. 3732 — MAXALT Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other. They are supplied as follows: NDC 0006-0266-18, carton of 18 tablets. No. 3733 — MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other. They are supplied as follows: NDC 0006-0267-18, carton of 18 tablets. No. 3800 — MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: NDC 0006-3800-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total). No. 3801 — MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: NDC 0006-3801-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total). Store MAXALT Tablets at room temperature, 15-30°C (59-86°F). Dispense in a tight container, if product is subdivided. Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15-30°C (59-86°F). The patient should be instructed not to remove the blister from the outer aluminum pouch until the patient is ready to consume the orally disintegrating tablet inside. MAXALT Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA By: MSD, Ltd. Cramlington, Northumberland, NE23 3JU, UK MAXALT-MLT Orally Disintegrating Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA By: Catalent UK Swindon, Zydis Ltd. Swindon, Wiltshire, SN5 8RU, UK US Patent No.: 5,298,520 Issued August 2010 9652508

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

MAXALT-MLT - RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING
MAXALT - RIZATRIPTAN BENZOATE TABLET
STAT RX USA LLC
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DESCRIPTION
MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine
(5-HT
) receptor
agonist.
Rizatriptan benzoate is described chemically as:
_N,N_-dimethyl-5-(1_H_-1,2,4-triazol-1-ylmethyl)-1_H_-
indole-3-ethanamine monobenzoate and its structural formula is:
Its empirical formula is C
H N •C H O , representing a molecular weight of the free base of
269.4.
Rizatriptan benzoate is a white to off-white, crystalline solid that
is soluble in water at about 42 mg per
mL (expressed as free base) at 25°C.
MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are
available for oral
administration in strengths of 5 and 10 mg (corresponding to 7.265 mg
or 14.53 mg of the benzoate salt,
respectively). Each compressed tablet contains the following inactive
ingredients: lactose monohydrate,
microcrystalline cellulose, pregelatinized starch, ferric oxide (red),
and magnesium stearate.
Each lyophilized orally disintegrating tablet contains the following
inactive ingredients: gelatin,
mannitol, glycine, aspartame, and peppermint flavor.
1
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Rizatriptan binds with high affinity to human cloned 5-HT
and 5-HT
receptors. Rizatriptan has weak
affinity for other 5-HT receptor subtypes (5-HT
, 5-HT
, 5-HT
) and the 5-HT receptor, but has
no significant activity at 5-HT , 5-HT , alpha- and beta-adrenergic,
dopaminergic, histaminergic,
muscarinic or benzodiazepine receptors.
Current theories on the etiology of migraine headache suggest that
symptoms are due to local cranial
vasodilatation and/or to the release of vasoactive and
pro-inflammatory peptides from sensory nerve
endings in an activated trigeminal system. The therapeutic activity of
rizatriptan in migraine can most
likely be attributed to agonist effects at 5-HT
receptors on the extracerebral, intracranial blood
vessels that become dilated during a migraine attack and on nerve
terminals in