Vifex

Vifex® (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

• Hyperkalemia (too much potassium in the blood).

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of Vifex (albuterol sulfate inhalation solution) administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver Vifex (albuterol sulfate inhalation solution) over 5 to 15 minutes.

The use of Vifex (albuterol sulfate inhalation solution) can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Vifex (albuterol sulfate inhalation solution) has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of Vifex (albuterol sulfate inhalation solution) solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Vifex (albuterol sulfate inhalation solution) have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of Vifex (albuterol sulfate inhalation solution) when administered with other nebulizer systems have not been established.

Vifex (albuterol sulfate inhalation solution) should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

How supplied

Vifex (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of Vifex (albuterol sulfate inhalation solution) (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches.

Vifex® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-692-03 5 foil pouches, each containing 5 vials, total 25 vials per carton

Vifex® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-693-03 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 2°C and 25°C (36°F - 77°F). Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

DEY®, Napa, CA 94558. JAN 07

See also:
What is the most important information I should know about Vifex?

Oral contraceptives should not be used in women who currently have the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebral vascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Severe hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast (or personal history of breast cancer)
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Hepatic tumors (benign or malignant) or active liver disease
• Known or suspected pregnancy
• Heavy smoking (≥15 cigarettes per day) and over age 35
• Hypersensitivity to any of the components of Vifex® (desogestrel and ethinyl estradiol) Tablets

Vifex is used to prevent reversible airways obstruction occurring during asthma, infections of airway passages (bronchitis), lung disorder in which the flow of air to the lungs is blocked (emphysema), and other lung diseases.

See also:
What other drugs will affect Vifex?

The concomitant use of Vifex (albuterol sulfate syrup) and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving Vifex (albuterol sulfate syrup). Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.

Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Vifex (albuterol sulfate syrup), but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, eg, as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Digoxin

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.

See also:
What are the possible side effects of Vifex?

Clinical Trial Experience: Adverse events reported in > 1% of patients receiving Vifex (albuterol sulfate inhalation solution) and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.

Table 1: Adverse Events with an Incidence of > 1% of Patients Receiving Vifex (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)

There was one case of ST segment depression in the 1.25 mg Vifex (albuterol sulfate inhalation solution) treatment group.

No clinically relevant laboratory abnormalities related to Vifex (albuterol sulfate inhalation solution) administration were seen in this study.

Postmarketing Experience

Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure..

Each 200 mcg/dose powder for inhalation solution contains Salbutamol sulphate equivalent to Vifex 200 mcg per metered dose. The dose, which the patient gets through the mouthpiece of the device is Vifex 180 mcg.

It contains lactose monohydrate (milk protein) as excipient.

The Vifex multiple dose powder inhaler contains 200 doses of finely powdered Vifex sulphate mixed in a small quantity of lactose. The amount of drug received by the patient (180 mcg/dose) corresponds to that from Vifex inhalation aerosol. The dose to be inhaled is released from the container by pressing the device between the thumb and forefinger. This is followed by inhalation through the device. As a result, Vifex particles are transferred to their target, the lungs. Use of the Vifex does not require coordination of actuation of the dose and inhalation.