Uprima
Uprima Brand: Apomorphine HCl Sublingual
Apomorphine HCl SL is indicated for the treatment of erectile dysfunction ,
which is the inability to achieve or maintain a penile erection sufficient for
satisfactory sexual performance. In order for apomorphine HCl SL to be
effective, sexual stimulation is required. Apomorphine HCl SL is not indicated
for use by women.
Before Using Uprima
Do not share thiis medicine with others for whom it was not prescribed. Do
not use this medicine for other health conditions. Keep this medicine out of the
reach of children.
Uprima Dosage
The recommended starting dose of apomorphine HCl SL tablets is 2 mg for all
patients. Subsequent Doses If necessary, the dose should be increased to a
maximal dose of 3 mg. The patient's dose should be adjusted to a dose that is
sufficient for sexual intercourse. A minimum of eight hours should be allowed to
elapse prior to administering a subsequent dose.
Uprima Cautions
Apomorphine HCl SL may produce a vasovagal autonomic syndrome that can
manifest as a brief self-limiting decrease in blood pressure and cause
fainting/syncope. Virtually all cases have occurred within the first two hours
of administration. The majority of cases have occurred after the first
apomorphine HCl SL dose or following an increase in dose. No subsequent fainting
episodes were reported in patients who had experienced syncope and continued
apomorphine HCl SL use. There is no evidence that apomorphine HCl SL causes
sustained blood pressure changes. Nearly all of synco-pal episodes were preceded
by a prodrome of symptoms that included one or more of the following: moderate
to severe nausea, vomiting, pallor, sweating/hot flashes (diaphoresis), and/or
dizziness/lightheadedness (see Adverse Reactions section). If patients
experience any of the prodromal symptoms listed above, they should not attempt
to stand-up, but should lie down and raise their legs until their symptoms
resolve. Each patient should be instructed to then contact their physician prior
to taking another dose. Studies on the effects on the ability to drive and use
machines have not been performed. Because some patients can experience
dizziness, lightheadedness, and uncommonly, syncope, they should not engage in
activities such as driving or operating machinery for at least two hours after
administration of apomorphine HCl SL or until any such symptoms are fully
resolved.
Uprima Important Fact
Apomorphine HCl SL should be used with caution in patients with uncontrolled
hypertension, known hypoten-sion or with a history of postural hypotension.
Acute decreases in blood pressure have been noted after apomor-phine HCl SL
administration. Elderly patients may be prone to such occurrences and are more
susceptible to any deleterious consequences. Apomorphine HCl SL should be used
with caution in patients taking antihypertensives or nitrate medications due to
the potential for hypotension. Apomorphine HCl SL should be used with caution in
patients with compromised renal or hepatic function. Agents for the treatment of
erectile dysfunction should be used with caution in patients with anatomical
penile deformity (such as angulation, cavernosal fibrosis, or Peyronie's
disease). The safety and efficacy of apomorphine HCl SL use with other
treatments for erectile dysfunction have not been studied. Therefore, the use of
such combination is not recommended.
Uprima Additional Infromation
Interaction studies and/or clinical experience with ondansetron
hydrochloride, prochlorperazine maleate and domperidome indicate that these
agents may be given safely with apomorphine HCl SL. No studies have been
performed with apomorphine HCl SL in combination with other antiemetics, hence
other combinations are not recommended. Apomorphine HCl SL should not be given
in combination with other centrally-acting dopamine agonists or antagonists
because of the potential for pharmacodynamic interactions. No formal drug
interaction studies have been performed with other agents for erectile
dysfunction, antidepres-sants, anticonvulsants or other CNS-active agents,
however clinical experience has not indicated the presence of interactions.
Interaction studies in volunteers where a lcohol was given with apomorphine HCl
SL indicated that concurrent alcohol intake may cause an increase in the
incidence and extent of hypotension. Additionally, intake of alcohol can
diminish sexual performance.
Directions for Uprima Use
The patient should drink a small amount of water before taking apomorphine
HCl SL to optimize the dissolution of the tablet. One tablet of apomorphine HCl
SL should be placed under the tongue approximately 20 minutes prior to sexual
activity. In the majority of patients the tablet will be completely dissolved
within ten minutes. If any residual amount remains in the mouth after 20 minutes
it may be swallowed. In order for apomorphine HCl SL to be effective, sexual
stimulation is required. The patient should initiate sexual activity and proceed
to intercourse when he feels ready. The median onset of effect is approximately
18 to19 minutes after the tablet is placed under the tongue. The onset time
varies from patient to patient.
Uprima Side Effects
Side effects cannot be anticipated.
Uprima Overdose
Overdosage has not been reported in any of the apomorphine HCl SL clinical
trials. Apomorphine HCl SL in high doses may induce vomiting. If the tablets are
swallowed the absorption of apomorphine will be reduced by first pass
metabolism. There is no specific antidote available for apomorphine HCl SL
tablets. Therefore, treatment should be supportive and symptomatic. It is
advised that vital signs such as blood pressure and heart rate are monitored.
Measures to avoid possible orthostatic hypotension should be taken. The use of a
dopamine antagonist may be considered.
