October 2002
FORMULARY
ADDITIONS
Brimonidine tartrate (Alphagan® P) 0.15%
Ophthalmic Solution 10 mL dropper bottles Brimonidine is indicated for lowering intraocular pressure in patients with open-angle glaucoma
or ocular hypertension. Brimonidine is an agonist
at alpha2 adrenergic and imidazoline receptors. It lowers intraocular
pressure by reducing aqueous humor production and increasing uveoscleral outflow. Pharmacologically it is most similar
to apraclonidine, however, apraclonidine is only
used to prevent postoperative spikes in intraocular
pressure. Alphagan®
P is a reformulation of Alphagan® 0.2%,
now discontinued. Alphagan® P was
developed to achieve comparable efficacy of Alphagan® and
improve its side-effect profile, particularly as it pertains to ocular
allergy. Brimonidine is contraindicated in patients with hypersensitivity to brimonidine or any other ingredient in the solution. It is also contraindicated in patients receiving monoamine oxidase inhibitors. Brimonidine should be used with caution in patients with severe cardiovascular disease, depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thromboangiitis obliterans, or a history of apraclonidine allergy. Use is also cautioned in patients on beta-blockers (ophthalmic and systemic), antihypertensives, and cardiac glycosides. The
most common adverse effects of brimonidine include
dry mouth, ocular hyperemia, burning and stinging, headache, blurring,
foreign body sensation, fatigue/drowsiness, conjunctival
follicles, ocular allergic reactions, and ocular pruritus. Intraocular pressure should be monitored
periodically throughout patient therapy. Periodic blood pressure monitoring
should also be considered, especially in patients taking antihypertensive
medications or medications that have been reported to lower systemic blood
pressure. Brimonidine may have an additive or potentiating effect with CNS depressants. Concomitant use with tricyclic
antidepressants may reduce the effects of brimonidine.
DOSAGE AND
ADMINISTRATION: The
recommended dose of brimonidine 0.15% is one drop
in the affected eye(s) three times daily, approximately 8 hours apart. Hepatitis A
Inactivated/Hepatitis B (Recombinant) Vaccine (Twinrix®) 720 ELISA
Units (ELU) and 20 mcg Hepatitis B surface antigen proteins Injection,
single-dose vials, single-dose pre-filled syringes (1 mL) Twinrix®
is a sterile bivalent vaccine containing the antigenic components used in
producing Havrix® (Hepatitis A Vaccine,
Inactivated) and Engerix-B® [Hepatitis B
Vaccine (Recombinant)]. Twinrix® is indicated for active
immunization of persons 18 years of age or older against disease caused by
hepatitis A virus and infection by all known subtypes of hepatitis B
virus. As with any vaccine,
vaccination with Twinrix® may not protect 100% of recipients. As
hepatitis D does not occur in the absence of HBV infection, it can be
expected that hepatitis D will also be prevented by vaccination with Twinrix®. Twinrix®
is contraindicated in people with known hypersensitivity to yeast or any
other component of the vaccine or monovalent
hepatitis A or hepatitis B vaccines. Twinrix® should be
administered with caution to people on anticoagulants, those with thrombocytopenia or a bleeding disorder since bleeding
may occur following intramuscular administration to
these subjects. The most commonly
reported adverse reactions following Twinrix® administration were
injection site reactions and upper respiratory tract infections.
DOSAGE
AND ADMINISTRATION:
Twinrix should be
administered by intramuscular injection. In adults,
the injection should be given in the deltoid region. Twinrix should not be administered in the gluteal
region; such injections may result in a suboptimal
response. Primary immunization for adults consists of three 1 mL doses, given on a 0-, 1- and 6-month schedule. The
vaccine is ready for use without reconstitution; it must be shaken before
administration. After shaking, the vaccine is a slightly turbid white
suspension. Moxifloxacin (AveloxŇ) 400 mg
tablets Moxifloxacin hydrochloride is a broad spectrum
antibacterial agent for oral administration. Moxifloxacin
is indicated for the treatment of adults of at least 18 years of age with
infections caused by susceptible microorganisms in acute sinusitis,
bronchitis and community acquired pneumonia. The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase)
and topoisomerase IV required for bacterial DNA
replication, transcription, repair, and recombination. MOXIFLOXACIN HAS
BEEN SHOWN TO PROLONG THE QT INTERVAL OF THE ELECTROCARDIOGRAM IN SOME
PATIENTS. THE DRUG SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF
THE QT INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA AND PATIENTS RECEIVING
CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE,
SOTALOL) ANTIARRHYTHMIC AGENTS. Convulsions and other CNS events have been reported in patients receiving quinolones. As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents. The
most commonly reported adverse reactions in moxifloxacin
treated patients are: nausea,
diarrhea, dizziness, headache, abdominal pain, vomiting, taste perversion,
abnormal liver function tests, and dyspepsia.
DOSAGE AND
ADMINISTRATION:
The standard dose
of moxifloxacin is one 400 mg tablet taken orally
every 24 hours. The duration of therapy depends on the type of
infection. Dose adjustments are not
necessary in hepatic or renal impairment. Moxifloxacin should be taken at least 4 hours
before or 8 hours after multivitamins (containing iron or zinc), antacids
(containing magnesium, calcium, or aluminum), sucralfate,
or Videx® (didanosine). Treprostinil (Remodulin®) 1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL as 20 mL multi-use vials Treprostinil is a vasodilator approved for the
treatment of pulmonary arterial hypertension (PAH) in New York Heart
Association (NYHA) Class II, III, and IV patients to diminish symptoms
associated with exercise. Treprostinil produces
direct vasodilation of pulmonary and systemic
arterial vessels and inhibits platelet aggregation. Treprostinil is contraindicated in patients with
known hypersensitivity to treprostinil,
structurally related compounds, or any of the other product ingredients
(sodium chloride, metacresol, sodium citrate,
sodium hydroxide, sodium hydrochloric acid). The most common adverse reactions reported with triprostinil therapy were infusion site pain, infusion site reactions, and bleeding or bruising. Headache, restlessness, nausea and diarrhea were also common. The hypotensive activity of treprostinil may be potentiated by other medications that also reduce blood pressure such as diuretics, antihypertensives, and vasodilators.
DOSAGE AND
ADMINISTRATION: The
starting dose of treprostinil is 1.25
ng/kg/min.
If the initial dose is not tolerated, the infusion rate should be
reduced to 0.625 ng/kg/min. Treprostinil
should be administered with caution in patients with hepatic or renal
insufficiency. In patients with
mild-to-moderate hepatic insufficiency, the initial dose should be reduced to
0.625 ng/kg/min ideal body weight and should be
increased cautiously. Safety and effectiveness have not been established in
pediatric patients. Dosages should be
adjusted cautiously in pediatric and elderly populations. Treprostinil is intended for subcutaneous
administration only. Treprostinil therapy should be directed by clinicians
experienced in the diagnosis and treatment of PAH. Therapy should be initiated in a setting
with adequate personnel and equipment for physiological monitoring and
emergency care. Chronic therapy should
be based on the patient’s ability to administer the drug and care for the
infusion system. Patients and
clinicians need to be aware that abrupt discontinuation or sudden large
dosage reductions may result in worsening pulmonary arterial hypertension. Bosentan (TracleerÔ) 62.5 mg and
125 mg film-coated tablets Bosentan is indicated for the long-term oral
treatment of primary and secondary pulmonary arterial hypertension in
patients with World Health Organization (WHO) Class III or IV symptoms to
improve exercise capacity and decrease the rate of clinical worsening. This agent is a nonpeptide,
specific, competitive endothelin (ET) receptor
antagonist. Bosentan
works by blocking endothelin receptors on vascular
endothelium and smooth muscle.
Stimulation of these receptors is associated with vasoconstriction. Bosentan is contraindicated in patients with
a history of hypersensitivity reaction to bosentan
or any of the product ingredients. Bosentan is contraindicated during
pregnancy. Bosentan
is in Pregnancy Category X and is very likely to produce major birth defects
if used during pregnancy. A pregnancy test must be obtained from patients
prior to initiation of therapy, and repeated monthly thereafter. Bosentan induces CYP 3A4 and CYP 2C9 and is
expected to reduce concentrations of substrates of these enzymes, including
hormonal contraceptives. The use of bosentan with cyclosporine or glyburide is contraindicated. Dose adjustments and/or patient monitoring
may be necessary when bosentan is administered with
simvastatin, warfarin and
digoxin. Elevations in ALT or AST at least 3 times the upper limit of normal have occurred in 10% to 13% of patients receiving bosentan and increases were accompanied by elevated bilirubin in some cases. Serum aminotransferase levels must be obtained prior to initiation of therapy, and then monthly thereafter. Hemoglobin concentrations should be monitored after 1 and 3 months of therapy, and then every 3 months thereafter. Bosentan therapy should generally be avoided in patients with moderate or severe hepatic impairment.
DOSAGE
AND ADMINISTRATION: Because of potential liver
injury and in an effort to make the chance of fetal exposure to Tracleer™ (bosentan) as small
as possible, Tracleer™ may be prescribed only
through the Tracleer™ Access Program. This program requires patient enrollment by
physician. Initiate
bosentan therapy at 62.5 mg twice daily for 4
weeks, then increase to 125 mg twice daily. In patients greater than 12 years
of age, but weighing less than 40 kg, the initial and maintenance dose should
be 62.5 mg twice daily. Bosentan tablets should be administered in the morning
and evening with or without food. It
is recommended that a reduction to 62.5 mg twice daily for 3 to 7 days be
considered prior to discontinuing therapy in order to reduce the potential
for clinical deterioration.
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