MIGRANOW- sumatriptan succinate, camphor, menthol kit
País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Características técnicas
(SPC)
11-01-2023
Enviar pedido.
Ingredientes ativos:
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Disponível em:
PureTek Corporation
DCI (Denominação Comum Internacional):
sumatriptan succinate
Composição:
SUMATRIPTAN 50 mg
Tipo de prescrição:
PRESCRIPTION DRUG
Indicações terapêuticas:
Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are 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 sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population. Sumatriptan tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not
Resumo do produto:
Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's. Bottles of 30 NDC 55111-291-30 Bottles of 36 NDC 55111-291-36 Bottles of 90 NDC 55111-291-90 Bottles of 100 NDC 55111-291-01 Bottles of 500 NDC 55111-291-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-291-09 Unit dose package of 100 (10 x 10) NDC 55111-291-78 Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's. Bottles of 30 NDC 55111-292-30 Bottles of 36 NDC 55111-292-36 Bottles of 90 NDC 55111-292-90 Bottles of 100 NDC 55111-292-01 Bottles of 500 NDC 55111-292-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-292-09 Unit dose package of 100 (10 x 10) NDC 55111-292-78 Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's. Bottles of 30 NDC 55111-293-30 Bottles of 36 NDC 55111-293-36 Bottles of 90 NDC 55111-293-90 Bottles of 100 NDC 55111-293-01 Bottles of 500 NDC 55111-293-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-293-09 Unit dose package of 100 (10 x 10) NDC 55111-293-78 Store at 20 to 25°C (68 – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Status de autorização:
unapproved drug other
Características técnicas
MIGRANOW- SUMATRIPTAN SUCCINATE, CAMPHOR, MENTHOL
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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MIGRANOW™ CONTAINS:
SUMATRIPTAN TABLETS USP AND CAMPHOTREX™ EXTRA STRENGTH PAIN
RELIEVING GEL
DESCRIPTION
Sumatriptan tablets USP contain sumatriptan (as the succinate), a
selective 5-
hydroxytryptamine
receptor subtype agonist. Sumatriptan succinate USP is chemically
designated as 3-[2- (dimethylamino)
ethyl]-N-methyl-indole-5-methanesulfonamide
succinate (1:1), and it has the following structure:
The molecular formula is C
H
N
O
S•C
H
O
, representing a molecular weight of
413.5. Sumatriptan succinate USP is a white to off-white powder that
is readily soluble in
water and in saline. Each sumatriptan tablet USP for oral
administration contains 35, 70,
or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg
of
sumatriptan, respectively. Each tablet also contains the inactive
ingredients
croscarmellose sodium, lactose anhydrous, lactose monohydrate,
magnesium stearate,
mannitol, microcrystalline cellulose, talc, titanium dioxide and
triacetin.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sumatriptan is an agonist for a vascular 5-hydroxytryptamine
receptor subtype
(probably a member of the 5-HT
family) having only a weak affinity for 5-HT
, 5-HT
, and 5-HT
receptors and no significant affinity (as measured using standard
radioligand binding assays) or pharmacological activity at 5-HT
, 5-HT
, or 5-HT
receptor subtypes or at alpha
, alpha
, or beta-adrenergic; dopamine
; dopamine
;
muscarinic; or benzodiazepine receptors.
The vascular 5-HT
receptor subtype that sumatriptan activates is present on cranial
arteries in both dog and primate, on the human basilar artery, and in
the vasculature of
human dura mater and mediates vasoconstriction. This action in humans
correlates with
the relief of migraine headache. In addition to causing
va
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