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Drug Study (DR)
Drug Study (DR)
Spastic states
Adults: 0.4 to 0.8 mg P.O.
Children: 0.006mg/kg I.V., I.M., or subcutaneously. Maximum dose, 0.3 mg. Dilute solution with
sterile water for solution before giving I.V.
Mode of Action:
Advise patient to apply patch the night before a planned trip. Transdermal method
releases a controlled therapeutic amount of drug. Transderm-Scop is effective if applied 2 or
3 hours before experiencing motion but is more effective if applied 12 hours before.
Instruct patient to remove one patch before applying another
Instruct patient to wash and dry hands thoroughly before and after applying the
transdermal patch (on dry skin behind the ear) and before touching the eye because pupil
may dilate. Tell patient to discard patch after removing it and to wash application site
thoroughly.
Tell patient that if patch becomes displaced, he should remove it and apply another patch
on a fresh skin site behind the ear.
Alert patient to possible withdrawal signs or symptoms (nausea, vomiting, headache,
dizziness) when transdermal system is used for longer than 72 hours.
Advice patient that eyes may be ore sensitive to light while wearing patch. Advice patient
to wear sunglasses for comfort
Urge patient to report urinary hesitancy or urine retention.
Duvadilan® [tab]
Solvay Pharma
MIMS Class : Drugs Acting on the Uterus
Isoxsuprine Hydrochloride
Pronouncation: (eye-SOX-you-preen HIGH-droe-KLOR-ide)
Class: Peripheral vasodilator
Trade Names:
Vasodilan
- Tablets 10 mg
- Tablets 20 mg
Trade Names:
Voxsuprine
- Tablets 10 mg
- Tablets 20 mg
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Pharmacology
Stimulates skeletal beta receptors to produce vasodilation; stimulates cardiac function (increased
contractility, heart rate, and cardiac output) and relaxes uterus. At higher doses, inhibits platelet
aggregation and decreases blood viscosity.
Pharmacokinetics
Absorption
Metabolism
Elimination
Onset
Special Populations
Neonates
Unlabeled Uses
Contraindications
Arterial bleeding; use during immediate postpartum period.
Dosage and Administration
Adults
PO 10 to 20 mg 3 or 4 times daily.
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Drug Interactions
None well documented.
Adverse Reactions
Cardiovascular
CNS
Dizziness; weakness.
Dermatologic
Severe rash.
GI
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Precautions
Pregnancy
Category C .
Lactation
Undetermined.
Patient Information
Instruct patient to report the following symptoms to health care provider: Fast
heartbeat, chest pain, pounding in chest, severe rash, flushing, weakness, nausea,
vomiting, stomach pain.
Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
Methergine®
(methylergonovine maleate) Tablets, USP
(methylergonovine maleate) Injection, USP
DRUG DESCRIPTION
WHAT ARE THE POSSIBLE SIDE EFFECTS OF METHYLERGONOVINE (METHERGINE)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing;
swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
INDICATIONS
For routine management after delivery of the placenta; postpartum atony andhemorrhage;
subinvolution. Under full obstetric supervision, it may be given in thesecond stage of labor following
delivery of the anterior shoulder.
1 mL, 0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during
the puerperium. May be repeated as required, at intervals of 2-4 hours.
Intravenously
Orally
One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
SIDE EFFECTS
The most common adverse reaction is hypertension associated in several cases
with seizure and/or headache. Hypotension has also been reported. Nausea and vomiting have
occurred occasionally. Rarely observed reactions have included:acute myocardial infarction, transient
chest pains, arterial spasm (coronary and
peripheral), bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication,
hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation,
rash, and foul taste.1
There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug
product.
Methergine® (methylergonovine maleate) has not been associated with drug abuse or dependence of
either a physical or psychological nature.
WARNINGS
This drug should not be administered I.V. routinely because of the possibility of inducing
sudden hypertensive and cerebrovascular accidents. If I.V. administration is considered essential as a
lifesaving measure, Methergine® (methylergonovine maleate) should be given slowly over a period of
no less than 60 seconds with careful monitoring of blood pressure. Intra-arterial or periarterial injection
should be strictly avoided.
PRECAUTIONS
General
Pregnancy
Category C. Animal reproductive studies have not been conducted with Methergine. It is also not
known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity.
Use of Methergine is contraindicated during pregnancy because of its uterotonic effects.
(SeeINDICATIONS AND USAGE.)
Labor and Delivery
The uterotonic effect of Methergine is utilized after delivery to assist involution and
decrease hemorrhage, shortening the third stage of labor.
Nursing Mothers
Pediatric Use
Geriatric Use
Clinical studies of Methergine did not include sufficient number of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience
has not identified differences in response between the elderly and younger patients. In general dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
OVERDOSE
Symptoms of acute overdose may include: nausea, vomiting, abdominal pain, numbness, tingling of
the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory
depression, hypothermia, convulsions, andcoma.
Also, several children 1-3 years of age have accidentally ingested up to 10 tablets (2 mg) with no
apparent ill effects. A postpartum patient took 4 tablets at one time in error and reported paresthesias
and clamminess as her only symptoms.
Treatment of acute overdosage is symptomatic and includes the usual procedures of:
CONTRAINDICATIONS
Hypertension; toxemia; pregnancy; and hypersensitivity.
2. Berde, B. and Schild, H.O.: Ergot Alkaloids and Related Compounds, Springer-Verlag, New York, 1978, p. 810.
3. Treatment of Acute Overdosage. Novartis Consumer Health, Inc. Rx Products. Novartis, Medical Services
Department.
CLINICAL PHARMACOLOGY
Methergine® (methylergonovine maleate) acts directly on the smooth muscle of the uterus and
increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and
sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. The
onset of action after I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after
oral administration, 5-10 minutes.
Pharmacokinetic studies following an I.V. injection have shown that methylergonovine is rapidly
distributed from plasma to peripheral tissues within 2-3 minutes or less. The bioavailability after oral
administration was reported to be about 60% with no accumulation after repeated doses. During
delivery, withintramuscular injection, bioavailability increased to 78%. Ergot alkaloids are mostly
eliminated by hepatic metabolism and excretion, and the decrease in bioavailability following oral
administration is probably a result of first-pass metabolism in the liver.
Bioavailability studies conducted in fasting healthy female volunteers have shown that oral absorption
of a 0.2 mg methylergonovine tablet was fairly rapid with a mean peak plasma concentration of 3243
± 1308 pg/mL observed at 1.12 ± 0.82 hours. For a 0.2 mg intramuscular injection, a mean peak
plasma concentration of 5918 ± 1952 pg/mL was observed at 0.41 ± 0.21 hours. The extent of
absorption of the tablet, based upon methylergonovine plasma concentrations, was found to be
equivalent to that of the I.M. solution given orally, and the extent of oral absorption of the I.M. solution
was proportional to the dose following administration of 0.1, 0.2, and 0.4 mg. When given
intramuscularly, the extent of absorption of Methergine solution was about 25% greater than the
tablet. The volume of distribution (Vdss/F) of methylergonovine was calculated to be 56.1 ± 17.0 liters,
and the plasma clearance (CLp/F) was calculated to be 14.4 ± 4.5 liters per hour. The plasma level
decline was biphasic with a mean elimination half-life of 3.39 hours (range 1.5 to 12.7 hours). A
delayed gastrointestinalabsorption (Tmax about 3 hours) of Methergine tablet might be observed
inpostpartum women during continuous treatment with this oxytocic agent.
USES:This medication is used after childbirth to help stop bleeding from the uterus. Methylergonovine
belongs to a class of drugs known as ergot alkaloids. It works by increasing the rate and strength of
contractions and the stiffness of the uterus muscles. These effects help to decrease bleeding.
HOW TO USE:Take this medication by mouth with or without food, usually 3 to 4 times daily for up to
1 week after delivery or as directed by your doctor.
Dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the
same times each day.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor
instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream.
Consult your doctor or pharmacist for more details.
SIDE EFFECTS:Headache, nausea, vomiting, or dizziness may occur. If any of these effects persist
or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the
benefit to you is greater than the risk of side effects. Many people using this medication do not have
serious side effects.
Tell your doctor immediately if any of these rare but serious side effects occur: fast/slow heartbeat,
shortness of breath, cold hands/feet, pain/redness/swelling of arms or legs.
Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, vision
changes, confusion, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you
notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the
face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact
your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA
at 1-800-FDA-1088 .
In Canada - Call your doctor for medical advice about side effects. You may report side effects to
Health Canada at 1-866-234-2345 .
PRECAUTIONS:Before taking methylergonovine, tell your doctor or pharmacist if you are allergic to it;
or to similar ergot alkaloids (such as ergonovine); or if you have any other allergies. This product may
contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your
pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney
disease, liver disease, high blood pressure, heart disease (such as venoatrial shunts, mitral valve
stenosis), blood vessel disease (such as Raynaud's disease), complications during pregnancy (such
as preeclampsia, eclampsia).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness
until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication must not be used during pregnancy. It may harm an unborn baby. Consult your
doctor for more details.
This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor
before breast-feeding.
STORAGE:Store at room temperature below 77 degrees F (25 degrees C) away from light and
moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly
discard this product when it is expired or no longer needed. Consult your pharmacist or local waste
disposal company for more details about how to safely discard your product.
VITAMIN K1
INJECTION
Phytonadione
Injectable Emulsion, USP
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless
liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol.
Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is indicated in the following coagulation
disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K
deficiency or interference with vitamin K activity.
other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to
interference with vitamin K metabolism, e.g., salicylates.
Whenever possible, Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) should be given by
the subcutaneous route. (See Box Warning.) When intravenous administration is considered
unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit.
Vitamin K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or
5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated
with toxicity in newborns. Therefore,all of the above diluents should be preservative-free (see
WARNINGS). Other diluents should not be used. When dilutions are indicated, administration should
be started immediately after mixture with the diluent, and unused portions of the dilution should be
discarded, as well as unused contents of the ampul.
The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single
intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended.
Empiric administration of vitamin K1 should not replace proper laboratory evaluation of the coagulation
mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following
administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to
respond indicates another diagnosis or coagulation disorder.
Vitamin K1 Injection 1 mg should be given either subcutaneously or intramuscularly. Higher doses
may be necessary if the mother has been receiving oral anticoagulants.
Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however,
does not correct the underlying disorder and Vitamin K 1 Injection should be given concurrently.
Effective for:
Pregnancy and breast-feeding: When taken in the recommended amount each day, vitamin
K is considered safe for pregnant and breast-feeding women, but don't use higher amounts
without the advice of your healthcare professional.
Kidney disease: Too much vitamin K can be harmful if you are receiving dialysis treatments
due to kidney disease.
Liver disease: Vitamin K is not effective for treating clotting problems caused by severe liver
disease. In fact, high doses of vitamin K can make clotting problems worse in these people.
SIDE EFFECTS
Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported
following parenteral administration. The majority of these reported events occurred
following intravenous administration.
Transient "flushing sensations" and "peculiar" sensations of taste have been observed with parenteral
phytonadione, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating,
brief hypotension, dyspnea, andcyanosis.
Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of
the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation
defect or that the condition being treated is unresponsive to vitamin K.
PRECAUTIONS
General
Vitamin K1 is fairly rapidly degraded by light; therefore, always protect MEPHYTON from light. Store
MEPHYTON in closed original carton until contents have been used. (See also HOW SUPPLIED,
Storage.)
Studies of carcinogenicity or impairment of fertility have not been performed with MEPHYTON.
MEPHYTON at concentrations up to 2000 mcg/plate with or without metabolic activation, was
negative in the Ames microbial mutagen test.
Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with MEPHYTON. It
is also not known whether MEPHYTON can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. MEPHYTON should be given to a pregnant woman only if
clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established with
MEPHYTON. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature
infants, have been reported with vitamin K.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when MEPHYTON is administered to a nursing woman.
Geriatric Use
Clinical studies of MEPHYTON did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger patients. In general, dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
OVERDOSE
The intravenous and oral LD50s in the mouse are approximately 1.17 g/kg and greater than 24.18
g/kg, respectively.
CONTRAINDICATIONS
Hypersensitivity to any component of this medication.
CLINICAL PHARMACOLOGY
MEPHYTON tablets possess the same type and degree of activity as does naturally-occurring vitamin
K, which is necessary for the production via the liverof active prothrombin (factor II), proconvertin
(factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). The
prothrombin test is sensitive to the levels of three of these four factors – II, VII, and X. Vitamin K is
an essential cofactor for a microsomal enzyme that catalyzes the posttranslational carboxylation of
multiple, specific, peptidebound glutamic acidresidues in inactive hepatic precursors of factors II, VII,
IX, and X. The resulting gammacarboxyglutamic acid residues convert the precursors into
activecoagulation factors that are subsequently secreted by liver cells into the blood.
Oral phytonadione is adequately absorbed from the gastrointestinal tract only ifbile salts are present.
After absorption, phytonadione is initially concentrated in the liver, but the concentration declines
rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic fate of vitamin
K. Almost no free unmetabolized vitamin K appears in bile or urine.
USES:Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors)
that your body naturally produces. These substances help your blood to thicken and stop bleeding
normally (e.g., after an accidental cut or injury). Low levels of blood clotting factors increase the risk
for unusual bleeding. Low levels may be caused by certain medications (e.g., warfarin) or medical
conditions (e.g., obstructive jaundice). Vitamin K helps to treat and prevent unusual bleeding by
increasing the body's production of blood clotting factors.
HOW TO USE:Take this medication by mouth exactly as directed by your doctor. Dosage is based on
your medical condition and response to treatment.
If you are using a certain "blood thinner" drug (warfarin), vitamin K can decrease the effects of
warfarin for up to 2 weeks. Therefore, be sure to take your vitamin K and warfarin exactly as directed
by your doctor or pharmacist.
If you develop easy bruising or bleeding, seek immediate medical attention. You may need another
dose of vitamin K.
SIDE EFFECTS:Vitamin K usually has very few side effects. If you have any unusual effects from
taking this medicine, tell your doctor or pharmacist promptly.
If your doctor has prescribed this medication, remember that he or she has judged that the benefit to
you is greater than the risk of side effects. Many people using this medication do not have serious
side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you
notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the
face/tongue/throat), severe dizziness, trouble breathing.
PRECAUTIONS:Before taking vitamin K, tell your doctor or pharmacist if you are allergic to it; or if
you have any other allergies.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood
disorders, gallbladder disease (e.g., obstructive jaundice, biliary fistula), liver disease.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and
benefits with your doctor.
It is not known whether this medication passes into breast milk. Consult your doctor before breast-
feeding.
STORAGE:Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light
and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly
discard this product when it is expired or no longer needed. Consult your pharmacist or local waste
disposal company for more details about how to safely discard your product.
Nubain® [amp]
Invida [ Zuellig ]
MIMS Class : Anaesthetics - Local & General, Analgesics (Opioid)