Atropine Sulfate (Isopto Atropine)

Trade Name : Isopto Atropine

Alcon Laboratories, Inc.

SOLUTION

Strength 10 mg/mL

Storage and handling for Isopto Atropine

ATROPINE SULFATE Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atropine Sulfate (Isopto Atropine) which is also known as Isopto Atropine and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 10 mg/mL per ml. Read more

Atropine Sulfate (Isopto Atropine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Delivery Process

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

No data

ISOPTO Atropine 1% is indicated for:
ISOPTOu00ae Atropine 1% is a muscarinic antagonist indicated for:

Mydriasis ()
Cycloplegia ()
Penalization of the healthy eye in the treatment of amblyopia ()

In individuals from three (3) months of age or greateru00a0 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time ()
In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. ()

Ophthalmic solution: 1% atropine sulfate (10mg/mL)
Ophthalmic solution: 1% atropine sulfate (10mg/mL) ()

Atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur.

Hypersensitivity or allergic reaction to any ingredient in the formulation ()

No data

Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks. ()
Risk of blood pressure increase from systemic absorption ()
Increased adverse drug reaction susceptibility with certain central nervous system conditions ()

The following adverse reactions are described below and elsewhere in the labeling:
The following adverse reactions have been identified following use of atropine sulfate ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate and blood pressure.u00a0()

The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.
The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ()

No data

In the event of accidental ingestion or toxic overdosage with atropine sulfate ophthalmic solution supportive care may include a short acting barbiturate or diazepam as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended.
Physostigmine, given by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.
Artificial respiration with oxygen may be necessary. Cooling measures may be needed to help to reduce fever, especially in pediatric populations.
The fatal pediatric and adult doses of atropine are not known.

ISOPTOu00ae Atropine 1% isu00a0 a sterile topical ophthalmic solution.u00a0Each mL of ISOPTOu00ae Atropine 1% contains 10 mg of atropine sulfateu00a0monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine.u00a0Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, u03b1-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, -()-, sulfate(2:1) (salt), monohydrate.u00a0Its molecular formula is (C17H23NO3)2 u2022 H2SO4 u2022 H2O and it is represented by the chemical structure:
Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83.
ISOPTOu00ae Atropine 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1.0% Preservative:u00a0benzalkonium chloride 0.01%
Inactive ingredients:u00a0

No data

Atropine sulfate was negative in the Salmonella/microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.

Topical administration of ISOPTOu00ae Atropine 1% results in mydriasis and/or cycloplegia, with efficacy demonstrated in both adults and children.u00a0The maximum effect for mydriasisu00a0is achieved in about 30u201340 minutes after administration, withu00a0recovery after approximatelyu00a07u201310 days.u00a0The maximum effect for cycloplegia is achieved within 60u2013180 minutes after administration, withu00a0recovery after approximately 7u201312 days.

ISOPTOu00ae Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINERu00ae dispensersu00a0withu00a0low-density polyethylene tips andu00a0red polypropylene caps as follows:
Storage: Store ISOPTOu00ae Atropine 1% at 2u201325u00b0C (36u201377u00b0F).

ALCONn

NDC 0065-0303-55n Alconn n Isopto Atropinen n- 5 mL Sterilen n- USUAL ADULT DOSAGE: n- PRECAUTION: n- STORAGE: n- Rx Onlyn INGREDIENTS: Each mL n- contains: Active: n- Arrayn- Arrayn- Alconn n- ALCON LABORATORIES, INC.n n- 9016388-0618n n n- SN:n n- LOT:n n- EXP.:n n- GTIN: 00300650303552
NDCn- Alconn n- Isopto Atropinen- (atropine sulfate ophthalmic solution) 1%n n- 5mLn- Rx Onlyn- INGREDIENTS: Each mL contains: n n- Active: n- Preservative: n- Inactives: n- Arrayn- Arrayn- Arrayn- Arrayn- H15250-0318
NDC n- Alconn n Isopto Atropine(atropine sulfate ophthalmic solution) 1.0%n- 15 mL n- Rx Onlyn INGREDIENTS: Each mL n- contains: Active: n- Arrayn- Arrayn- Arrayn- USUAL ADULT DOSAGE: n- PRECAUTION: n- STORAGE: n- Alconn n- 9013897-1216n- LOT:u00a0u00a0u00a0u00a0u00a0 EXP.:
NDCn- Alconn n- Isopto Atropinen- (atropine sulfate ophthalmic solution) 1%n n- 15 mLn n- Rx Onlyn- INGREDIENTS: Each mL contains: n n- Active: n- Preservative: n- Inactives: n- Arrayn- Arrayn- Arrayn- Arrayn- H14702-1216

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