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SCHEDULING STATUS:
Schedule 3
PROPRIETARY NAME:
(and dosage form)
Retrosternal pain may occur due to increased gastric reflux. Hypersensitivity may occur as
conjunctivitis or a skin rash.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness,
confusion and excitement, and hallucinations passing into delirium. A rash may appear on
the face and upper trunk. In severe intoxication, depression of the central nervous system
may occur with hypertension or with circulatory failure and respiratory depression.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
IDENTIFICATION
Clear, colourless solution.
PRESENTATION:
Sterile, single-dose disposable eye drops in cartons of 10 units, each containing
approximately 0,5 mL.
STORAGE INSTRUCTIONS:
Store in the refrigerator protected from strong light. DO NOT FREEZE.
Keep out of reach of children.
REGISTRATION NUMBER:
C/15.4/51
NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
Pinetown 3610
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 21, 1970.
9/67H
* Trademark
SNP 26/2
PENJADWALAN STATUS:
Jadwal 3
KEPEMILIKAN NAMA:
(Dan bentuk sediaan)
KOMPOSISI:
(Per dispensing unit 0,5 mL)
Homatropine hidrobromida 10 mg.
Farmakologi KLASIFIKASI:
Sebuah persiapan Kedokteran 15,4: lainnya
Farmakologi AKSI:
Homatropine hidrobromida memiliki sifat parasympatholytic mirip dengan atropin,
tetapi jauh lebih lemah. Mydriasis terjadi dalam 15-30 menit dan melewati off dalam
6-24 jam. Mydriasis mudah dikontrol oleh physostigmine. Pada anak-anak
homatropine tidak biasanya menghasilkan cycloplegia lengkap.
INDIKASI:
Homatropine hidrobromida digunakan dalam oftalmologi sebagai mydriatic, dan
sebagai suatu cycloplegic.
KONTRA-INDIKASI:
Homatropine hidrobromida tidak boleh diberikan kepada pasien dengan glaukoma
sudut tertutup atau pasien dengan sudut sempit antara iris dan kornea, karena
penggunaannya dapat menyebabkan tekanan intra-okular meningkat.
KETENTUAN PENDAFTARAN:
Periklanan ke profesi saja.
IDENTIFIKASI
Jelas solusi, tidak berwarna.
PRESENTASI:
Steril, dosis tunggal mata pakai tetes dalam karton dari 10 unit, masing-masing
berisi sekitar 0,5 mL.
PENYIMPANAN INSTRUKSI:
Simpan dalam lemari es terlindung dari cahaya yang kuat. JANGAN FREEZE.
Jauhkan dari jangkauan anak-anak.
PENDAFTARAN NOMOR:
C/15.4/51
HOMATROPINE HBR
HOMATROPINE HBR
Rekomendasi Dosis: Dosis mydriasis Dewasa: 1-2 tetes larutan 2% topikal pada
mata (s), ulangi dalam 5-10 menit jika diperlukan; Uveitis: 1-2 tetes larutan 2%
topikal pada mata (s) setiap 3 - 4 jam. Dosis Pediatric mydriasis: 1-2 tetes larutan
2% topikal pada mata (s) setiap 10 menit selama 2-3 dosis sebelum bias; Uveitis: 12 tetes larutan 2% topikal pada mata (s) 2 atau 3 kali per hari
DESCRIPTION:
Homatropine Hydrobromide ophthalmic solution is a sterile solution for
ophthalmic administration in drop form, having the following composition:
Plastic squeeze bottle
Homatropine Hydrobromide 20-50 mg/mL (cycloplegic-mydriatic) in a
buffered aqueous solution containing boric acid, potassium chloride, edetate
disodium and water for injection, preserved with benzalkonium chloride. The
chemical name is 1H, 3H-Tropan-3-o1mandelate (ester) hydrobromide. It
has the following chemical structure:
INACTIVE INGREDIENTS:
Boric Acid, Potassium Chloride, Edetate Disodium, and Water for Injection
USP.
Preservative: Benzalkonium Chloride USP 0.01% v/v
CLINICAL PHAMACOLOGY:
Homatropine Hydrobromide causes wide dilation of the pupil and
paralysis of accommodation. Dilation is more rapid than with atropine but
cycloplegia is not as pronounced and does not last as long.
INDICATIONS AND USAGE:
Homatropine Hydrobromide is indicated for treatment of iritis and
iridocyclitis, for relief of ciliary spasm, and also as an aid in refraction. It is
frequently employed as a cycloplegic and mydriatic in preoperative and
postoperative conditions.
CONTRAINDICATIONS:
Contraindicated in the presence of an anatomically narrow angle or in
individuals with primary glaucoma and in individuals hypersensitive to one or
more of the components of this preparation including the belladonna alkaloid
group.
WARNINGS:
In infants and pediatric patients use with extreme caution. Excessive use in
pediatric patients or certain individuals with a history of susceptibility to
belladonna alkaloids may produce systemic symptoms of homatropine
poisoning (see overdosage section).
PRECAUTIONS:
Caution should be exercised when driving with dilated pupils or when
engaging in hazardous activities. Parents of children should be cautious not
to get the drug into the childs mouth and to wash both the childs and their
hands after use of the drug.
If eye pain occurs from use of this medication, the patient should be advised
to discontinue use and see prescribing physician immediately as this may
indicate undiagnosed glaucoma. Use cautiously in elderly or hypertensive
patients.
To avoid excessive systemic absorption, the lacrimal sac should be
compressed by digital pressure for one minute after instillation.
Not for internal use. To prevent contaminating the dropper tip and solution,
care should be taken not to touch the eyelids or surrounding area with the
dropper tip of the bottle.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
There have been no long-term studies using homatropine in animals to
evaluate carcinogenic potential.
Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been done with
homatropine. It is also not known whether homatropine can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
Homatropine should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Since homatropine is absorbed systemically and since it is detectable in very
small amounts in human milk, and because of the potential for serious
adverse reactions in nursing infants from homatropine, a decision should be
made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
PEDIATRIC USE:
Homatropine should not be used during the first three months of life due to a
possible association between the cycloplegia produced and the development
of the amblyopia.
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS:
Prolonged use may produce local irritation characterized by follicular
conjunctivitis, vascular congestion, edema, exudate, and eczematoid
dermatitis. Systemic homatropine toxicity is manifested by flushing and