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MINIMS* HOMATROPINE HYDROBROMIDE 2%

SCHEDULING STATUS:
Schedule 3
PROPRIETARY NAME:
(and dosage form)

MINIMS* HOMATROPINE HYDROBROMIDE 2%


Eye Drops
COMPOSITION:
(per dispensing unit of 0,5 mL)
Homatropine hydrobromide 10 mg.
PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations: other
PHARMACOLOGICAL ACTION:
Homatropine hydrobromide has parasympatholytic properties similar to those of atropine,
but is much weaker. Mydriasis occurs within 15-30 minutes and passes off in 6-24 hours.
Mydriasis is readily controlled by physostigmine. In children homatropine does not usually
produce complete cycloplegia.
INDICATIONS:
Homatropine hydrobromide is used in ophthalmology as a mydriatic, and as a cycloplegic.
CONTRA-INDICATIONS:
Homatropine hydrobromide should not be administered to patients with closed-angle
glaucoma or to patients with a narrow angle between the iris and the cornea, since its use
may cause intra-ocular pressure to rise.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children: To be used as directed by the ophthalmologist. For simple dilation of the
pupil a 1% solution is usually adequate but for full paralysis of accommodation 3-4 drops of
a 2% solution may have to be instilled every 15 minutes for 1-2 hours.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Homatropine hydrobromide should be used with caution in patients with prostatic
enlargement and in patients suffering from paralytic ileus or pyloric stenosis. Systemic
reactions may follow the absorption of homatropine hydrobromide from eye drops. Dryness
of the mouth with difficulty in swallowing, thirst, dilation of the pupils with loss of
accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of
the skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, a desire to
urinate with the inability to do so, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Vomiting, giddiness and staggering may occur.

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

Minims * HOMATROPINE HIDROBROMIDA 2%

PENJADWALAN STATUS:
Jadwal 3

KEPEMILIKAN NAMA:
(Dan bentuk sediaan)

Minims * HOMATROPINE HIDROBROMIDA 2%


Eye Drops

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.

DOSIS DAN PETUNJUK UNTUK PENGGUNAAN:


Dewasa dan anak-anak: Untuk digunakan sebagai diarahkan oleh dokter spesialis
mata. Untuk pelebaran sederhana murid larutan 1% biasanya memadai tetapi untuk
kelumpuhan penuh tetes akomodasi 3-4 dari larutan 2% mungkin harus ditanamkan
setiap 15 menit selama 1-2 jam.

EFEK SAMPING DAN PENCEGAHAN KHUSUS:


Homatropine hidrobromida harus digunakan dengan hati-hati pada pasien dengan
pembesaran prostat dan pada pasien yang menderita ileus paralitik atau stenosis
pilorus. Reaksi sistemik dapat mengikuti penyerapan hidrobromida homatropine dari
obat tetes mata. Kekeringan mulut dengan kesulitan menelan, haus, pelebaran
pupil dengan kehilangan akomodasi dan fotofobia, peningkatan tekanan intraokular, pembilasan dan kekeringan pada kulit, bradycardia diikuti oleh takikardia,
palpitasi dan aritmia dengan, keinginan untuk buang air kecil dengan
ketidakmampuan untuk melakukannya, serta pengurangan dalam nada dan
motilitas pada saluran gastro-intestinal menyebabkan sembelit. Muntah, pusing dan
mengejutkan dapat terjadi. Nyeri retrosternal dapat terjadi karena refluks lambung
meningkat. Hipersensitivitas dapat terjadi sebagai konjungtivitis atau ruam kulit.

DIKENAL gejala overdosage DAN KETERANGAN DARI PENGOBATAN ITS:


Dosis beracun menyebabkan takikardia, respirasi cepat atau sesak, hiperpireksia,
gelisah, kebingungan dan kegembiraan, dan halusinasi melewati ke delirium. Ruam
dapat muncul pada batang wajah dan bagian atas. Pada keracunan yang parah,
depresi dari sistem saraf pusat dapat terjadi dengan hipertensi atau dengan
kegagalan sirkulasi dan depresi pernapasan.

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

NAMA DAN USAHA ALAMAT PEMOHON:


S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Jalan
Pinetown 3610

TANGGAL PUBLIKASI INI INSERT PAKET:


21 Oktober 1970.
9/67H
* Merek SNP 26/2

HOMATROPINE HBR

Dosage Form: Eye drop 2% (II)

Recommended Dose: Adult dose Mydriasis: 1-2 drops of 2% solution TOPICALLY in


eye(s), repeat in 5-10 min if needed; Uveitis: 1-2 drops of 2% solution TOPICALLY in
eye(s) every 3-4 hr. Pediatric dose Mydriasis: 1-2 drops of 2% solution TOPICALLY in
eye(s) every 10 min for 2-3 doses prior to refraction; Uveitis: 1-2 drops of 2%
solution TOPICALLY in eye(s) 2 or 3 times per day

Indications: Treatment of anterior segment inflammation

Contra-Indications: Primary glaucoma, narrow anterior chamber angle.

Special Precaution: Infant and small children.

HOMATROPINE HBR

Dosis Bentuk: Eye penurunan 2% (II)

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

Indikasi: Pengobatan peradangan segmen anterior

Kontra-Indikasi: Primer glaukoma, sudut ruang sempit anterior.

Perhatian khusus: Bayi dan anak-anak kecil.

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

dryness of the skin (a rash may be present in children), dryness of the


mouth, anhidrosis, blurred vision, photophobia, loss of neuromuscular
coordination (ataxic gait), a rapid and irregular pulse, fever, abdominal and
bladder distention, dysarthric quality of speech, and mental aberration
(hallucinosis) with recovery frequently followed by retrograde amnesia.
OVERDOSAGE:
When signs and symptoms of homatropine toxicity develop (see adverse
reactions section), physostigmine should be administered parenterally (for
dosage refer to Goodman & Gilman or other pharmacology reference). In
infants and pediatric patients, the body surface must be kept moist.
DOSAGE AND ADMINISTRATION:
Usual dosage is one or two drops of the 2% or 5% solution in the eye(s) two
or three times a day, modified at discretion of physician.
For refraction: One or two drops of the 2% solution every 10-15 minutes for 5
doses or one or two drops of the 5% solution repeated in 15 minutes,
modified at discretion of the physician.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN, OR MISSING.
HOW SUPPLIED:
5% solution: 5 mL plastic dropper tip squeeze bottle.
KEEP BOTTLE TIGHTLY CLOSED WHEN NOT IN USE. PROTECT FROM
LIGHT.
STORE AT CONTROLLED ROOM TEMPERATURE 15-30C (59-86F).
Manufactured for: HUB Pharmaceuticals, LLC
Rancho Cucamonga, CA 91730
REPRESENTATIVE PACKAGING: