Date of approval.
Date of modification.
Synthroid®
Avastin Capsules Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Acrivastine Capsules
English Name: Acrivastine Capsules
Hanyu Pinyin：Afasiting Jiaonang
Ingredients
The main ingredient of this product is Acrivastine.
Chemical name: (E)-3-[6-[(E)-1-(4-methylphenyl)-3-pyrrolidin-1-yl-1-propenyl]pyridin-2-yl]-2-propenoic acid
Chemical structure formula.
Molecular formula: C22H24N2O2
Molecular weight: 348.45
Properties
The content of this product is white or off-white granules or powder.
Indications】
It is indicated for the relief of allergic rhinitis, including the disease symptoms of kwashiorkor fever, and also for chronic spontaneous urticaria, skin scarring, cholinergic urticaria and idiopathic acquired cold urticaria.
Specification】 8mg
Dosage]
Take orally. Adults and children over 12 years old: one capsule (8mg) three times a day.
Adverse reactions]
The safety of Avastin was evaluated based on data from 10 placebo-controlled clinical trials of this variety in 373 subjects reporting adverse events with an incidence of ≥1%. In addition, adverse drug reactions (ADRs) from the post-marketing experience of this variety were included.
Incidence was defined according to the following convention: very common ≥ 1/10, common ≥ 1/100 and <1/10, occasional ≥ 1/1000 and <1/100, rare ≥ 1/10,000 and <1/1000, very rare <1/10000, unknown (could not be estimated from available data).
Known ADRs are listed based on the following frequency categories: 1) incidence in adequately designed clinical trials or epidemiologic studies, if available, or 2) when incidence is not available, the frequency category is listed as unknown.
Identified as an adverse drug reaction in post-marketing experience with Avastin. Frequency category estimates are from clinical trials or epidemiologic studies. soc Frequency category Adverse drug reactions (preferred term) Immune system Unknown allergic reactions (including dyspnea and facial swelling) Nervous system Very common Drowsiness Common dizziness Gastrointestinal tract Common dry mouth Skin and subcutaneous tissue Unknown rash [Contraindication].
This product is contraindicated in patients with known hypersensitivity to Avastin and Triprolidine.
Because avastin is primarily cleared by the kidneys, and avastin has not been studied in patients with renal failure, this product should not be used in this patient population.
It is contraindicated in patients with severe renal insufficiency.
Precautions]
(1) Keep out of the reach of children.
(2) Do not drink grapefruit juice at the same time as taking this product.
(3) Simultaneous administration of Avastin and central nervous system depressants, including alcohol, sedatives and sleeping pills, may cause additional harm to mental alertness in some people. As with all antihistamines, excessive alcohol consumption should be avoided while taking this product.
(4) Patients with renal insufficiency, patients taking sedatives, tranquilizers, ketoconazole or erythromycin should consult a physician before taking this product.
(5) This product contains lactose and should not be taken by patients with galactose intolerance, Lapp lactase deficiency or rare genetic disorders of glucose-galactose malabsorption.
(6) Effects on driving and operating machinery: Avastin may cause dizziness and drowsiness. Because of the individual differences in all drugs, it is reasonable to caution all patients when engaging in mentally alert work (e.g., driving, operating machinery) after using this drug unless the patient is familiar with his or her reaction to the drug.
Use in Pregnant and Lactating Women
Avastin is not recommended for use in pregnant or nursing women unless the potential benefit to the mother outweighs the potential risk to the fetus or nursing infant.
Fertility
In animal reproduction studies, systemic administration of Avastin to animals did not produce embryotoxic or teratogenic effects and did not impair fertility.
Pregnancy
There are no adequate and well-controlled studies in the pregnant women population.
Lactation
It is not known whether avastin will be present in breast milk and its concentration after administration of this product.
Pediatric Dosage]
There is no information available on the use of this product in children under 12 years of age.
Geriatric use
There are no specific studies of this product in elderly patients. Until further information is available, this product should not be used in elderly patients (65 years of age or older).
Drug Interactions]
Under the influence of alcohol and other central nervous system depressants, patients are usually not advised to perform tasks that require maintaining mental concentration. In some patients, concomitant administration of alcohol and Avastin may result in additional impairment.
There are no data on the interaction of Avastin with ketoconazole, erythromycin, or grapefruit juice, as these substances interact with other non-sedating antihistamines and caution should be taken when combined.
[Drug overdose].
Symptoms
Overdose of Avastin has been reported to cause drowsiness, restlessness, hyperactivity and tachycardia.
Taking more than the recommended dose of Avastin has been found to reduce driving ability. This effect is related to the extent to which Avastin exceeds the recommended maximum daily dose.
Treatment
When an overdose of this product occurs, appropriate symptomatic treatment, including activated charcoal treatment and gastric lavage, should be administered.
[Pharmacology and Toxicology
Pharmacodynamics
Avastin is a potent competitive histamine H1 receptor antagonist with no significant anticholinergic effect and low penetration into the central nervous system. It can relieve symptoms caused by histamine by completely or partially blocking its release.
Toxicological studies
Genotoxicity.
No mutagenicity was seen in real mutagenicity and L5178y/tk+/- lymphatic analysis of Salmonella Ames. In in vitro cytogenetic studies in human lymphocytes, avastin failed to induce chromosomal abnormalities. A single oral dose of Avastin up to 1000 mg/kg (5900 mg/ m2, i.e. 249 times the recommended daily human dose) in rats did not reveal normal chromosomal abnormalities in in vivo cytogenetic studies.
Reproductive toxicity.
The administration of Avastin alone to rats at 200 mg/kg/day (1180 mg/m2/day, 50 times the recommended human daily dose) had no effect on the fertility of female and male rats.
Pregnancy: Teratogenic effects.
No teratogenic effects were observed in rats and rabbits given Avastin 1000 and 400 mg/kg/day (5900 and 4720 mg/m2/day, i.e. 249 and 200 times the recommended human daily dose), respectively. In perinatal and postnatal studies in rats given avastin 500 mg/kg/day (2950 mg/m2/day, i.e. 124 times the recommended human daily dose) alone, mortality in mothers and neonates was dose-level dependent.
Carcinogenicity.
No potential carcinogenic effects were observed in rats given 40mg/kg/day (236mg/m2/day, 10 times the recommended human daily dose) orally alone for 20-22 months, and in mice given up to 250mg/kg/day (750mg/m2/day, 32 times the recommended human daily dose) for 20-24 months.
Pharmacokinetics
Avastin is well absorbed through the intestinal tract. The peak plasma concentration (Cmax) of the drug after 8 mg of Avastin in healthy adult volunteers was about 150 ng/ml at about 1.5 hours (Tmax). plasma half-life was about 1.5 hours. No drug accumulation of Avastin was observed in a 6 day multi-dose study. Plasma protein binding was approximately 50%, primarily to albumin. Avastin is mostly excreted in its original form in the urine, and renal excretion is the main route of elimination of avastin.
Storage】Store under 30℃ in airtight place under shade.
The product should be stored in the original package after opening.
Package]: Polyvinyl chloride/polyvinylidene chloride solid pharmaceutical compound hard tablets and pharmaceutical aluminum foil packaging, 12 capsules/plate/box, 10 capsules/plate x 2 plates/box.
Expiration date】 18 months
Execution Standard
Approval number】 State Drug Administration H20083406
【Marketing license holder
Company name: Chongqing Huabang Pharmaceutical Co.
Registered Address: No. 69, Xingguang Avenue, Renhe, Yubei District, Chongqing
Postal Code: 401121
Telephone number: 023-67034120 800-8070618 (need to use a landline to call)
Fax number: 023-67886970
http://www.huapont.cn
[Manufacturer
Company name: Chongqing Huabang Pharmaceutical Co.
Address: No. 69, Renhe Xingguang Avenue, Yubei District, Chongqing
Postal Code: 401121
Telephone number: 023-67034120 800-8070618 (need to use a landline to call)
Fax number: 023-67886970
http://www.huapont.cn
If you have any questions, please contact with the manufacturer directly