500IU
contains the substance called as its active
ingredient. Inactive ingredients of include human albumin, lactose and
protein from cow’s milk.
was originally developed for the
treatment of neurological and ophthalmic conditions in the early 1990s
in the United Kingdom and has established clinical success. Patients
with excessive sweating under the armpits (axillary hyperhidrosis) are
also treated with this product.
is manufactured by Ipsen
Biopharm Ltd., a British company with headquarters in Wrexham, UK. is
exclusively distributed by Tercica, Inc., a subsidiary company of Ipsen
Group with headquarters at Brisbane, CA and Medicis Aesthetics Inc., a
wholly owned subsidiary of Medicis Pharmaceutical Corporation with
headquarters at Scottsdale, AZ.
Pharmacological Action
contains substance called that relaxes the muscle. Botulinum toxin is
derived from Clostridium botulinum bacteria that intercept the discharge
of acetylcholine from the nerve endings that causes the contraction of
muscles.
For the improvement of the appearance of glabellar
lines, temporarily impede the tightening of muscles found between the
eyebrows for about 4 months.
For the treatment of abnormal head
position and neck pain caused by cervical dystonia (CD), lessens the
muscle spasm that causes the CD by softening the muscle for about 12 to
16 weeks. Neck pain and abnormal head position as symptoms to CD is
thereby reduced.
works in two functions, which is by inhibiting
the release of acetylcholine and at the same time blocks the
neuromuscular activity.
Indication
is indicated for the treatment of the following conditions specifically indicated in the medication guide:
Abnormal head position (spasmodic torticolitis) and neck pain brought
about by the condition called cervical dystonia (CD) in adults,
Temporary improve the appearance of moderate to severe frown lines found
between the eyebrows (glabellar lines) in patients younger than 65
years old.
500IU? is also prescribed for the medication of the following condition:
Arm spasticity (stiffness in the arm muscles) that occurs following a
stroke. Equinus foot deformity (abnormal ankle position and walking
gait) caused by cerebral palsy spasticity in children 2 years old or
older. Blepharospasm (a condition affecting the eyelid). This condition
losses the persons’ control on the blinking and closure of his eyelids.
Hemifacial spasm (a condition affecting the face muscle). Persons’
affected with this condition losses control on his face muscle, enabling
it to contract without control.
Mode of Administration
is administered through intramuscular injection on the affected muscles.
It should be performed by a health care provider who is trained and has
the skill of identifying the essential attributes of muscles.
For
the treatment of cervical Dystonia: is administered with the initial
divided dose of 500IU? given through intramuscular injection in affected
muscles. Depending upon the result of treatment and patient’s response
to medication, may be administered every 12-16 weeks or as prescribed by
Doctor with a dosage between 250 to 1000 units.
For the
improvement of Glabellar lines: is administered intramuscularly in the
affected muscles not exceeding the total dose of 50 Units, divided in 10
aliquot units or for 5 equal dosages.
Intervals or frequency for
re-treatment must not transpire less than 3 months (12 weeks) following
the previous injection or administration.
Contraindications and Cautions
is contraindicated to persons who have an allergic reaction to any
ingredients. It is important to inform your Doctor if you have either an
infection on the possible site for injection or are allergic to the
following substance:
Protein from cow’s milk Botulinum toxin such as or Myobloc
Persons
who have the following symptoms or conditions are advised to tell your
Doctor of your concern and the possible effect of on your current
condition:
Asthma or Emphysema Abnormal sugar level or Diabetes Bleeding problems Irregular heartbeat
and Breastfeeding. It is not known whether passes in to breast milk. It
is however important to inform your Doctor if you are breast feeding a
baby to avoid harm to the nursing infant.
and Pregnancy. FDA
classified under the C category for pregnancy. should be used with
caution on pregnant women, as such; benefits should exceed the risk that
is involved in the use of this medication.
may cause muscle weakness and must not be taken by persons who are operating machinery or driving a vehicle.
is generally not recommended to patients under 18 years old.
Side Effects
Like
any medication, side effects may occur on the use of this medication.
The side effect that is associated on the use of varies from moderate to
serious classification.
Moderate or less serious side effects: The following side effects will diminish after couple of hours:
Discomfort and pain at the injection site Headache Tired feeling Muscle
pain Neck pain Mild allergic reaction such as itching, rash, dizziness
and faint Dropping eyelids Blurred vision
Serious side effects:
Immediately seek medical intervention if any of the following side
effects occurs. Spread of toxin may cause serious side effects in the
area outside the injection site and is usually accompanied by the
following symptoms:
Dysphonia (change or loss of voice or the
occurrence of hoarse voice ) Dysarthria ( trouble speaking a word
clearly) Breathing trouble Swallowing problem Severe wheezing and asthma
symptoms Loss of bladder control
It is important to inform your doctor right away if you have any discomfort or unnatural occurrence in your present condition.
Drug Interactions
Drug
interactions will normally affect the efficacy of the treatment. There
is no solid study that is conducted on the possible interaction of to
certain medication.
The following treatment that interferes with neuromuscular transmission may affect the efficacy of :
Aminoglycosides (curare-like agents) Anticholinergic drugs Other Botulinum Neurotoxins
It
is however important to inform your medical practitioner of any
medication you are currently taking for him to have a complete
assessment of its possible interaction with .
Interesting facts
is already existing for more than 2 decades and was first to have
gained the approval for treatment of neuromuscular conditions in New
Zealand.
Currently, it has received the approval for the
treatment of frown lines and excessive sweating under the armpits. Such
fact is registered under the New Zealand Medicines Act.