Consumer medicine information

1. Why am I using Bimatoprost Sandoz?

Bimatoprost Sandoz eye drops contain the active ingredient bimatoprost. Bimatoprost Sandoz is used to lower raised pressure in the eye and to treat glaucoma.
For more information, see Section 1. Why am I using Bimatoprost Sandoz? in the full CMI.

2. What should I know before I use Bimatoprost Sandoz?

Do not use if you have ever had an allergic reaction to bimatoprost or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Bimatoprost Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Bimatoprost Sandoz and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Bimatoprost Sandoz?

• Use one drop in your affected eye(s), according to your doctor's instructions.

• Use the drops each evening.

5. What should I know while using Bimatoprost Sandoz?

6. Are there any side effects?

The most common side effects include red, congested eyes, growth of eyelashes, itching or irritation of the eye. Note that side effects can occur in other parts of the body, including serious allergic reaction (anaphylaxis).
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Bimatoprost.

2 Qualitative and Quantitative Composition

Bimatoprost Sandoz 300 microgram/mL is a sterile ophthalmic solution. Each mL of Bimatoprost Sandoz solution contains active ingredient bimatoprost 0.3 mg.
Bimatoprost is a prostamide with potent ocular hypotensive activity. Bimatoprost is a white or almost white crystalline powder and is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost is a clear, isotonic, colourless, sterile ophthalmic solution with an osmolality of approximately 260 to 330 mOsmol/kg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Bimatoprost Sandoz 300 microgram/mL eye drops sterile solution is packed in plastic dropper bottles with a plastic tamper-proof screw cap. Each bottle has a fill volume of 3 mL.

4 Clinical Particulars

4.9 Overdose

In case of overdose treatment should be supportive and symptomatic.
Ophthalmic overdose. No case of overdose has been reported, and is unlikely to occur after ocular administration.
Systemic overdose resulting from accidental ingestion. If bimatoprost is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 250 mg/kg/day did not produce any toxicity. This dose expressed as mg/kg is 1,100 times higher than the accidental dose of one bottle (7.5 mL) of bimatoprost in a 10 kg child.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Ocular administration of bimatoprost in monkeys at concentrations of 0.03% or 0.1% once or twice daily for 1 year caused an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure. No associated increase in melanocyte number was observed with the pigmentation. It appears that the mechanism of increased iris pigmentation is due to increased stimulation of melanin production in melanocytes and not to an increase in melanocyte number.
Periocular effects were also observed in an intravenous toxicity study at systemic exposures at least 235-fold higher than that observed in humans after ocular administration. No functional or microscopic changes related to the periocular effects were observed. The mechanism of action for the observed periocular changes is unknown.
Genotoxicity. Bimatoprost was not mutagenic or clastogenic in a bacterial mutation assay, in a mouse lymphoma test in vitro or in a mouse micronucleus test.
Carcinogenicity. Long-term studies in mice and rats revealed no evidence of carcinogenicity following oral (by gavage) administration of bimatoprost at doses up to 2 and 1 mg/kg/day, respectively. These doses resulted in systemic bimatoprost levels 85 - 95 times the maximum anticipated human exposure (based on blood AUC). In the rat carcinogenicity study, a dose-related increase in vacuolated corpora lutea was observed. The clinical relevance of this ovarian effect is unclear.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBIMATO.gif Chemical name: (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[1E,3S)-3-hydroxy-5-phenyl-1-pentenyl] cyclopentyl]-5-N-ethylheptenamide.
Molecular weight: 415.58.
Empirical formula: C₂₅H₃₇NO₄.
CAS number. 155206-00-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BIMSANST.gif