Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies in Crl:CD(SD)BR rats and NMRI mice were conducted to assess the carcinogenic potential of Cobatect hydrochlor >2 basis). No ev >2 basis).
Cobatect hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.
There were no effects on male or female fertility and reproductive performance in male and female rats at oral doses up to 30 mg/kg (approximately 180 times the MRHD >2 basis). At 68.6 mg/kg (approximately 410 times the MRHD >2 basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, preimplantation loss was not increased.
Central Nervous System Depressants
Concurrent use of Cobatect HCl Nasal Solution (Nasal Spray), 0.15% with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur .
COMMON BRAND(S): Optivar
GENERIC NAME(S): Cobatect
OTHER NAME(S): Cobatect Drops
This medication is used to treat itching eyes caused by allergies (allergic conjunctivitis). Cobatect belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for allergic symptoms.
Do not use this medication to treat redness and irritation due to wearing contact lenses.
Perennial Allergic Rhinitis
Children 6 to 11 years of age: Cobatect hydrochloride nasal spray, 0.15%, 1 spray per nostril twice daily.
Adults and adolescents 12 years of age and older: Cobatect hydrochloride nasal spray, 0.15%, 2 sprays per nostril twice daily.
There have been no reported overdosages with Cobatect HCl nasal solution (nasal spray). Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence, since one 30-mL bottle of Cobatect HCl Nasal Solution (Nasal Spray), 0.15% contains up to 45 mg of Cobatect hydrochloride. Clinical trials in adults with single doses of the oral formulation of Cobatect hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to Cobatect HCl nasal solution (nasal spray). Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, Cobatect HCl Nasal Solution (Nasal Spray), 0.15% should be kept out of the reach of children.
What other information should I know?
If a young child accidentally eats Cobatect, call a doctor or a poison control center immediately.
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
The efficacy and safety of Cobatect HCl nasal solution (nasal spray), 0.15% in seasonal allergic rhinitis was evaluated in five randomized, multicenter, double-blind, placebo-controlled clinical trials in 2499 adult and adolescent patients 12 years and older with symptoms of seasonal allergic rhinitis (Trials 2, 3, 4, 5, and 6). The population of the trials was 12 to 83 years of age (64% female, 36% male; 81% white, 12% black, Treatment (sprays per month) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value Trial 1 Two sprays twice daily Cobatect HCl nasal solution (nasal spary), 0.1% 146 18.0 -5.0 -2.2 -3.2, -1.2
Table 4: Mean Change from Baseline AM Instantaneous TNSS over 2 Weeks* in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis Treatment (sprays per nostril once daily) n Baseline LS Mean Change from Baseline Difference From Placebo LS Mean 95% CI P value Trial 4 Two sprays once daily Cobatect HCl nasal solution (nasal spary), 0.15% 238 8.1 -1.3 -0.2 -0.6, 0.1 0.15 Vehicle Placebo 242 8.3 -1.1 Trial 5 Two sprays once daily Cobatect HCl nasal solution (nasal spary), 0.15% 266 8.7 -1.4 -0.7 -1.0, -0.4
Cobatect HCl nasal solution (nasal spray), 0.15% at a dose of 1 spray twice daily was not studied. The Cobatect HCl nasal solution (nasal spray), 0.15% 1 spray twice daily dosing regimen is supported by previous findings of efficacy for Cobatect HCl nasal solution (nasal spray) without sweetener and a favorable comparison of Cobatect HCl nasal solution (nasal spray), 0.15% to Cobatect HCl nasal solution (nasal spray) without sweetener and Cobatect HCl nasal solution (nasal spray), 0.1% (Table 3).
Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ Cobatect hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Seasonal Allergic Rhinitis
Cobatect Hydrochloride 0.15% Nasal Spray
The efficacy and safety of Cobatect hydrochloride 0.15% in seasonal allergic rhinitis was evaluated in five randomized, multicenter, double-blind, placebo-controlled clinical trials in 2499 adult and adolescent patients 12 years and older with symptoms of seasonal allergic rhinitis (Trials 2, 3, 4, 5, and 6). The population of the trials was 12 to 83 years of age (64% female, 36% male, 81% white, 12% black, Table 4. Mean Change from Baseline in Reflective TNSS over 2 Weeks* in Adults and Children ≥ 12 years with Seasonal Allergic Rhinitis
How is Cobatect applied
Adults and children from the age of twelve contact Cobatect eye drops usually twice daily. In this case, one drop is introduced in the eye. With severe symptoms, the application can be carried out up to four times a day. On the hygienic handling of the eye drops should be strictly respected (first doing hand washing, do not touch the eye with the opening of the vial, observe the shelf life after opening – this is usually four weeks)
Unless otherwise prescribed, contact adults and children over twelve years, the Cobatect nasal spray twice daily with a spray per nostril at. Before the first use, the spray should be repeatedly actuated to fill the pumping mechanism. In children, it can be useful to apply the nasal spray with slightly sloping forward head. So runs less of the bitter-tasting solution down the throat and is tasted in the mouth.
Cobatect tablets should be taken twice a day with a glass of water before or after eating. Patients older than 65 years or with a hepatic or renal impairment should begin treatment with one tablet daily in the evening. Following doctor’s prescription, the tablets have already been authorized in children aged six and over.
Erythromycin and Ketoconazole
Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral Cobatect hydrochlor >see Clinical Pharmacology (12.2) and (12.3) ].
Drug-drug. Cimetidine: increased mean Cmax and area under the curve of orally administered Cobatect
CNS depressants: additional decreased alertness and impairment of CNS performance (with Astelin, Astepro)
Drug-behaviors. Alcohol use: decreased alertness and impairment of CNS performance (with Astelin, Astepro)
Cobatect 0.05% (Optivar) is a second-generation H 1 receptor antagonist. It was demonstrated in a pediatric SAC study that the response rate in the Cobatect eye drops group (74%) was significantly higher than that in the placebo group (39%) and comparable with that in the levocabastine group. 73 Apart from the ability to inhibit histamine release from mast cells and to prevent the activation of inflammatory cells, it is likely that the antiallergic potency of Cobatect is partially the result of down-regulation of ICAM-1 expression during the early- and late-phase components of ocular allergic response, probably leading to a reduction of inflammatory cell adhesion to epithelial cells and confirming the prophylactic properties of Cobatect. 74 It is safe to use in children 3 years and older.
How should this medicine be used?
Ophthalmic Cobatect comes as a solution (liquid) to instill in the eye. It is usually instilled in the affected eye(s) twice a day. To help you remember to use Cobatect, use it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Cobatect exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Before using Cobatect,
- tell your doctor and pharmacist if you are allergic to Cobatect or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other cold and allergy products, antihistamines, and vitamins.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Cobatect, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using Cobatect.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.