Maxidex

Pregnancy Category: C

Lactation: Excretion in milk unknown/use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Dexamethasone is a prescription medication used to relieve inflammation and treat a variety of conditions that involve swelling, heat, redness, and pain in many body systems.

Dexamethasone belongs to a group of drugs called corticosteroids. These work by replacing natural hormones produced by your adrenal glands when your body cannot make enough.

This medication is available as an oral concentrate, an oral elixir, an oral solution, an oral tablet, eye drops, and ear drops. The directions and frequency of use will vary with the indication for dexamethasone.

This medication is also available as an intravitreal implant for injection into the eye by a healthcare professional.

This medication is also available in an injectable form to be given directly into a vein (IV), a muscle (IM), a joint (intra-articular), a lesion (intralesional), and soft tissue by a healthcare professional.

Common side effects of dexamethasone include upset stomach, vomiting, headache, insomnia, restlessness, depression, anxiety, acne, increased hair growth, easy bruising, increased appetite and weight gain, and irregular or absent menstrual periods.

Dexamethasone can also cause dizziness. Do not drive or operate heavy machinery until you know how dexamethasone affects you.

Serious side effects have been reported with dexamethasone. See the “Dexamethasone Precautions” section.

Oral and injectable forms:

Common side effects of oral and injectable forms of dexamethasone include the following:

• upset stomach
• stomach irritation
• vomiting
• headache
• dizziness
• insomnia
• restlessness
• depression
• anxiety
• acne
• increased hair growth
• easy bruising
• irregular or absent menstrual periods
• increased appetite and weight gain

Intravitreal form:

Common side effects of the dexamethasone intravitreal implant include increased intraocular pressure and conjunctival hemorrhage.

This is not a complete list of dexamethasone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dexamethasone, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dexamethasone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take dexamethasone exactly as prescribed.

This medication is available as an oral concentrate, an oral elixir, an oral solution, an oral tablet, and eye and ear drops. Your doctor will prescribe the dose and schedule for use that is appropriate for your condition. Oral forms of dexamethasone may be taken with food or milk to decrease the risk of an upset stomach.

This medication is also available as an intravitreal implant for injection directly into the eye by a healthcare professional.

This medication is also available in an injectable form to be given directly into a vein (IV), a muscle (IM), a joint (intra-articular), a lesion (intralesional), and soft tissue by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of dexamethasone at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will prescribe the dexamethasone dose and schedule that is appropriate for your condition. Do not abruptly stop taking dexamethasone.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Maxidex® 0.1% (dexamethasone ophthalmic suspension) is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is represented by the chemical structure:

Chemical name: Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α)-.

Each mL contains: Active: dexamethasone 0.1%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose 0.5%. Inactives: sodium chloride, dibasic sodium phosphate, polysorbate 80, edetate disodium, citric acid and/or sodium hydroxide (to adjust pH), purified water.

Contraindicated in epithelial herpes simplex (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; tuberculosis of the eye; fungal disease of ocular structures; and in those persons who have shown hypersensitivity to any component of this preparation.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.