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Combigan

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Combigan

Combigan

Combigan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) is used to treat glaucoma or ocular hypertension (high pressure inside the eye). Brimonidine is an alpha agonist, and timolol is a beta-blocker. Both work to reduce pressure inside the eye. Common side effects include temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, dry mouth, feeling as if something is in the eye, headache, dizziness, or drowsiness.

The recommended dose is one drop of Combigan in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, they should be instilled at least 5 minutes apart. Combigan may interact with antidepressants, blood pressure medications, cimetidine, digoxin, HIV /AIDS medicines, antihistamines, antifungal antibiotics, anti-malaria medications, medicines to treat psychiatric disorders, heart rhythm medications, calcium channel blockers, or beta-blockers. Tell your doctor all medications and supplements you use. During pregnancy, Combigan should be used only when prescribed. This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Our Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Combigan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • pounding heartbeats or fluttering in your chest;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • feeling like you might pass out;
  • numbness, tingling, or cold feeling in your hands or feet;
  • muscle weakness; or
  • confusion, hallucinations, unusual thoughts or behavior.

Less serious side effects may include:

  • mild burning, stinging, or itching of your eyes;
  • dry eyes, blurred vision;
  • mildly swollen or puffy eyes;
  • feeling like something is in your eye;
  • weakness, tired feeling;
  • cough, sore throat;
  • nausea, upset stomach;
  • headache;
  • drowsiness;
  • unusual or unpleasant taste in your mouth;
  • sensitivity to light;
  • dry nose;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Combigan (Brimonidine Tartrate, Timolol Maleate Ophthalmic Solution .2%/.5%) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Combigan Overview - Patient Information: Side Effects

SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, dry mouth, feeling as if something is in the eye, headache, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye sensitivity to light, eye pain/swelling/discharge, slow/irregular heartbeat, muscle weakness, unusual tiredness, mental/mood changes, coldness/numbness/pain in the hands or feet, swelling ankles/feet, sudden unexplained weight gain, shortness of breath.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, weakness on one side of the body, slurred speech, confusion, persistent dizziness, fainting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Combigan (Brimonidine Tartrate, Timolol Maleate Ophthalmic Solution .2%/.5%)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Combigan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

COMBIGAN®

In clinical trials of 12 months duration with COMBIGAN® , the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance.

Other adverse reactions that have been reported with the individual components are listed below.

Brimonidine Tartrate (0.1%-0.2%)

Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid disorder, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, taste perversion, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

Timolol (Ocular Administration)

Body as a whole: chest pain; Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud's phenomenon, syncope, and worsening of angina pectoris; Digestive: Anorexia, diarrhea, nausea; Immunologic: Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss; Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis; Hypersensitivity: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash; Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, nasal congestion, respiratory failure; Endocrine: Masked symptoms of hypoglycemia in diabetes patients [see WARNINGS AND PRECAUTIONS]; Special Senses: diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, refractive changes, tinnitus; Urogenital: Decreased libido, impotence, Peyronie's disease, retroperitoneal fibrosis.

Postmarketing Experience

The following reactions have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions, timolol ophthalmic solutions, or both in combination, in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, timolol ophthalmic solutions, or a combination of these factors, include: depression, eyelid erythema extending to the cheek or forehead, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), and tachycardia. In infants, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported [see CONTRAINDICATIONS and Use in Specific Populations].

Oral Timolol/Oral Beta-blockers

The following additional adverse reactions have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a whole: Decreased exercise tolerance, extremity pain, weight loss; Cardiovascular: Vasodilatation, worsening of arterial insufficiency; Digestive: Gastrointestinal pain, hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, vomiting; Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura; Endocrine: Hyperglycemia, hypoglycemia; Skin: Increased pigmentation, pruritus, skin irritation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: An acute reversible syndrome characterized by disorientation for time and place, decreased performance on neuropsychometrics, diminished concentration, emotional lability, local weakness, reversible mental depression progressing to catatonia, slightly clouded sensorium, vertigo; Respiratory: Bronchial obstruction, rales; Urogenital: Urination difficulties.

Read the entire FDA prescribing information for Combigan (Brimonidine Tartrate, Timolol Maleate Ophthalmic Solution .2%/.5%) »

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Combigan - User Reviews

Combigan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Combigan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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