Drug Study

Methergine
Drug Description
Methergine®
(methylergonovine maleate) Tablets, USP
Methergine® (methylergonovine maleate) is a semi-synthetic ergot alkaloid used for the
prevention and control of postpartum hemorrhage. Methergine is available in tablets for oral
ingestion containing 0.2 mg methylergonovine maleate.

Indications
Following delivery of placenta, for routine management of uterine atony, hemorrhage and
subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor
following delivery of the anterior shoulder.

Dosage
Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration.
1. Intramuscularly
 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.
2. Intravenously
 1 mL, 0.2 mg, administered slowly over a period of no less than 60 seconds (See
WARNINGS.)
3. 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. Abdominal pain (caused by uterine
contractions), nausea and vomiting have occurred occasionally. Rarely observed reactions have
included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm,
coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water
intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea,
diaphoresis, palpitation, rash, and foul taste. There have been rare isolated reports of
anaphylaxis, without a proven causal relationship to the drug product.

Contraindications
Hypertension; toxemia; pregnancy; and hypersensitivity.

Oxytocin
Drug Description
Pitocin®
(Oxytocin) Injection, USP Synthetic
Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic
oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in
pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL
and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, with the pH adjusted
with acetic acid. Pitocin may contain up to 16% of total impurities. The hormone is prepared
synthetically to avoid possible contamination with vasopressin (ADH) and other small
polypeptides with biologic activity. Pitocin has the empirical formula C43H66N12O12S2
(molecular weight 1007.19).

Indication
Important Notice
Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no
medical indications for induction. Since the available data are inadequate to evaluate the
benefits to- risks considerations, Pitocin is not indicated for elective induction of labor.
Antepartum
Pitocin is indicated for the initiation or improvement of uterine contractions, where this is
desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve
vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for
the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term,
when delivery is in the best interests of mother and fetus or when membranes are prematurely
ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases
of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable
abortion. In the first trimester, curettage is generally considered primary therapy. In second
trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other
means of therapy, however, may be required in such cases.
Postpartum
Pitocin is indicated to produce uterine contractions during the third stage of labor and to control
postpartum bleeding or hemorrhage.

Dosage
Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration whenever solution and container permit.
The dosage of oxytocin is determined by the uterine response and must therefore be
individualized and initiated at a very low level. The following dosage information is based upon
various regimens and indications in general use.
Induction Or Stimulation Of Labor
Intravenous infusion (drip method) is the only acceptable method of parenteral administration of
Pitocin for the induction or stimulation of labor. Accurate control of the rate of infusion is
essential and is best accomplished by an infusion pump. It is convenient to piggyback the Pitocin
infusion on a physiologic electrolyte solution, permitting the Pitocin infusion to be stopped
abruptly without interrupting the electrolyte infusion. This is done in the following way.

Side Effects
The following adverse reactions have been reported in the mother:
 Anaphylactic reaction  Fatal afibrinogenemia
 Premature ventricular contractions  Hypertensive episodes
 Postpartum hemorrhage  Nausea
 Pelvic hematoma  Rupture of the uterus
 Cardiac arrhythmia  Vomiting
 Subarachnoid hemorrhage
Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm,
tetanic contraction, or rupture of the uterus.
The possibility of increased blood loss and afibrinogenemia should be kept in mind when
administering the drug.
Severe water intoxication with convulsions and coma has occurred, associated with a slow
oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water
intoxication has been reported.

Contraindications
Antepartum use of Pitocin is contraindicated in any of the following circumstances:
 Where there is significant cephalopelvic disproportion;
 In unfavorable fetal positions or presentations, such as transverse lies, which are
undeliverable without conversion prior to delivery;
 In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother
favors surgical intervention;
 In fetal distress where delivery is not imminent;
 Where adequate uterine activity fails to achieve satisfactory progress;
 Where the uterus is already hyperactive or hypertonic;
 In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma,
active herpes genitalis, total placenta previa, vasa previa, and cord presentation or
prolapse of the cord;
 In patients with hypersensitivity to the drug
 Evening Primrose
GENERIC NAME(S): Evening Primrose Oil
Uses
Evening primrose oil has been used for breast pain (including breast pain related to the
menstrual cycle).
Evening primrose oil has not been shown to be effective for preventing or treating cancer. If you
have cancer or think you may have cancer, consult your doctor.
Some herbal/dietary supplement products have been found to contain possibly harmful
impurities/additives. Check with your pharmacist for more details about the brand you use.
The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or
pharmacist for more details.

How to use Evening Primrose

Take this product by mouth as directed. Follow all directions on the product package. If you are
uncertain about any of the information, consult your doctor or pharmacist.
If your condition persists or worsens, or if you think you may have a serious medical problem,
seek immediate medical attention.

Side Effects
Upset stomach, nausea, soft stools, or headache may occur. If any of these effects persist or
worsen, contact your doctor or pharmacist promptly.
A very serious allergic reaction to this product is rare. However, seek immediate medical
attention if you notice any of the following symptoms of a serious allergic reaction: rash,
itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Precautions
Before taking evening primrose oil, tell your doctor or pharmacist if you are allergic to it; 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.
If you have any of the following health problems, consult your doctor or pharmacist before using
this product: bleeding or clotting problems.
Liquid products may contain sugar and/or alcohol. Caution is advised if you have diabetes,
alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product
safely.
This product is not recommended for use during pregnancy. Consult your doctor before using this
product.
This product passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor
before breast-feeding.

Interactions
Before using this product, tell your doctor or pharmacist of all prescription and
nonprescription/herbal products you may use, especially of: medications/herbal products that
may increase your risk of bleeding (e.g., "blood thinners" such as warfarin and heparin, anti-
platelet drugs such as clopidogrel, nonsteroidal anti-inflammatory drugs-NSAIDs such as
ibuprofen, herbals such as danshen/garlic/ginger).
Aspirin may also increase the risk of bleeding when used with this product. If your doctor has
directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of
81-325 milligrams a day), you should continue taking it unless your doctor instructs you
otherwise. Consult your doctor for more information.
This product may interfere with certain laboratory tests (bleeding time, cholesterol levels),
possibly causing false test results. Make sure laboratory personnel and all your doctors know you
use this product.
Do not start, stop, or change the dosage of any medicine before checking with your doctor or
pharmacist first.
This document does not contain all possible interactions. Therefore, before using this product,
tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with
you, and share the list with your doctor and pharmacist.

Laminaria

What other names is Laminaria known by?

 Algue Brune, Brown Algae, Brown Seaweed, Hai Dai, Kelp, Kombu, Kun Bu, Laminaire,
Laminaire Digitée, Laminaire Japonaise, Laminaria digitata, Laminaria japonica, Laminariae
stipites, Limu, Makombu Thallus, Sea Girdles, Seagirdle Thallus, Thallus Laminariae.

What is Laminaria?
 Laminaria is a type of seaweed that is native to Japan. Laminaria contains iodine, an
element that the body needs to make thyroid hormones. It is also a rich source of iron and
potassium. Despite serious safety concerns about laminaria, some people use laminaria as
medicine.
 Laminaria is used for weight loss, high blood pressure, as a bulk laxative for constipation,
and for treating radiation sickness. It is also used for preventing cancer.
 Sometimes healthcare providers use laminaria to expand the cervix, the mouth of the
uterus, before certain medical procedures. They place a layer of laminaria directly inside
the cervix, the “neck” of the uterus. This layer of laminaria is sometimes called a “tent.”
The purpose of the tent is to enlarge the cervix before “D&C,” also known as dilation
and curettage (scraping of the uterus); removal of a medical device that is in the uterus;
diagnostic procedures; placement of radium for cancer treatment; and other gynecological
procedures. Laminaria tents are also used in pregnant women to “ripen” (expand) the
cervix to make labor and delivery easier, and also to cause abortions during the first three
months of pregnancy.

Possibly Ineffective for...

Preparation ("ripening") of the cervix in women, such as during childbirth or procedures.
Although laminaria might speed up childbirth, it doesn't seem to reduce the number of women
who need Cesarean sections to deliver. Laminaria also increases the chance of infection in both
mother and infant.
Insufficient Evidence to Rate Effectiveness for...
 Weight loss.
 High blood pressure.
 Cancer prevention.
 Heartburn.
Other conditions.
 More evidence is needed to rate the effectiveness of laminaria for these uses.

How does Laminaria work?

Laminaria seems to be able to form a thick, sticky gel when it comes into contact with water. This
allows laminaria to work as a bulk laxative. It also allows laminaria “tents” that have been placed
inside the cervix to expand the cervix for procedures or to “ripen” the cervix and speed up the
onset of labor. These laminaria tents absorb water, gradually swelling to a diameter of 1/2 inch
over 4-6 hours. This swelling causes the cervix to expand, and that can bring on labor.

Carboprost
Generic Name: carboprost (KAR boe prost)
Brand Name: Hemabate
What is carboprost?
 Carboprost is a form of prostaglandin (a hormone-like substance that occurs naturally in
the body). Prostaglandins help to control functions in the body such as blood pressure and
muscle contractions.
 Carboprost is used to treat severe bleeding after childbirth (postpartum).
 Carboprost is also used to produce an abortion by causing uterine contractions. It is
usually given between the 13th and 20th weeks of pregnancy, but may be given at other
times for medical reasons. Carboprost is often used when another method of abortion has
not completely emptied the uterus, or when a complication of pregnancy would cause the
baby to be born too early to survive.
Important Information
 You should not receive carboprost if you have active pelvic inflammatory disease, a
breathing disorder, heart disease, liver disease, or kidney disease.
This medicine in given in a hospital or clinic setting to quickly treat any serious side effects that
occur.

Before taking this medicine

You should not receive carboprost if you are allergic to it, or if you have:
 active pelvic inflammatory disease;  heart disease;
 kidney disease; or
 a lung disorder or breathing problem;  liver disease.

To make sure carboprost is safe for you, tell your doctor if you have:

 high or low blood pressure;  any scarring in your uterus;

 diabetes;  a history of asthma; or
 epilepsy or other seizure disorder;  a history of heart, kidney, or liver
disease

How is carboprost given?

 Carboprost is given as an injection into a muscle. You will receive this injection in a clinic or
hospital setting.
 You may be given medication to prevent nausea, vomiting, or diarrhea while you are
receiving carboprost.
 To be sure this medication has been effective, your cervix (opening of the uterus) will need
to be checked after the procedure. Do not miss any scheduled follow-up visits to your
doctor.
In some cases, carboprost may not produce a complete abortion and the procedure must be
repeated.

Carboprost side effects

 Get emergency medical help if you have any of these signs of an allergic reaction: hives;
difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

 severe pelvic pain, cramping, or  shortness of breath
vaginal bleeding;  severe nausea, vomiting, or diarrhea;
 high fever; or
 a light-headed feeling, like you might  increased high blood pressure (severe
pass out; headache, blurred vision, buzzing in
 your ears, anxiety, confusion, chest
pain).
Common side effects may include:

 mild nausea, vomiting, diarrhea;  cough, hiccups;

 mild fever, chills;  headache; or
 flushing (warmth, redness, or tingly  mild pelvic pain or menstrual-type
feeling); cramps.

Uses:
-Aborting pregnancy between the 13 th and 20 th weeks of gestation (calculated from the first
day of the last normal menstrual period)
-Failure of expulsion of the fetus during the course of treatment by another method
-Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or
absent uterine activity
-Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus
-Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and
absence of adequate activity for expulsion

Further information

 Remember, keep this and all other medicines out of the reach of children, never share
your medicines with others, and use this medication only for the indication prescribed.
 Always consult your healthcare provider to ensure the information displayed on this page
applies to your personal circumstances.
 Carboprost Pregnancy Warnings: Carboprost does not appear to directly affect the
placental unit; therefore, it is possible that a previable fetus aborted by carboprost could
exhibit transient life signs. Studies in animals do not indicate teratogenicity; however,
reproductive toxicity has been shown and any dose, which produces increased uterine
tone, could put the embryo or fetus at risk.

Carbetocin (Systemic)
VA CLASSIFICATION
Primary: GU600
Commonly used brand name(s): Duratocin.
Indications

 Accepted
Atony, uterine (treatment) or Hemorrhage, postpartum (treatment)—Carbetocin is indicated in
the management of uterine atony and postpartum bleeding or hemorrhage following elective
cesarean section performed under epidural or spinal anesthesia.{01}

 Unaccepted
Appropriate studies have not been performed to establish the safety and efficacy of carbetocin
following classical or emergency cesarean section or when anesthesia other than epidural or
spinal is used. Safety and efficacy also have not been established following vaginal delivery.{01}

Medical considerations/Contraindications

The medical considerations/contraindications included have been selected on the basis of their
potential clinical significance (reasons given in parentheses where appropriate)— not necessarily
inclusive (» = major clinical significance).

Except under special circumstances, this medication should not be used when the
following medical problem exists:
» Allergy to oxytocin or carbetocin
Risk-benefit should be considered when the following medical problems exist
» Vascular disease, especially coronary artery disease
safety and efficacy in the presence of this condition have not been established; if used, extreme
caution is recommended

Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical
significance (possible signs and symptoms in parentheses where appropriate)—not necessarily
inclusive:
Those indicating need for medical attention
 Incidence more frequent  Anemia (pale skin; unusual tiredness
 Abdominal pain or weakness)
 flushing }(feeling of warmth)  anxiety (nervousness)
 headache  chest pain
 hypotension (dizziness ; faintness ; or  chills
light-headedness)  dyspnea (shortness of breath)
 pruritus (itching skin)  pain
 tremor (trembling)  tachycardia (fast heartbeat)
 Incidence less frequent

Those indicating need for medical attention only if they continue or are bothersome

 Incidence more frequent  Back pain

 Nausea  dizziness
 vomiting  metallic taste
 Incidence less frequent  sweating

General Dosing Information

 Carbetocin should not be administered prior to the delivery of the infant.

 Carbetocin has a long duration of action compared with oxytocin. Therefore, once uterine
contractions have started, they cannot be stopped by discontinuing the medication.
 Although carbetocin may be administered before or after delivery of the placenta, if it is
administered before, partial retention or trapping of the placenta theoretically could occur.
However, no cases have been reported.
 If a single dose of carbetocin is not sufficient to induce adequate uterine contractions,
more aggressive treatment with ergotamine or higher doses of oxytocin is recommended.
Additional carbetocin should not be administered.
 If persistent bleeding occurs, the possibility of coagulopathy, retained placental fragments,
or trauma to the genitourinary tract should be explored.

Parenteral Dosage Forms

CARBETOCIN INJECTION
Usual Adult Dose
Atony, uterine (treatment) or
Hemorrhage, postpartum (treatment)
 Single intravenous bolus injection, 100 micrograms over 1 minute following the delivery of
the infant(s) by cesarean section under epidural anesthetic{01}
Strength(s) usually available: U.S.—
Not commercially available.: Canada—
100 mcg per mL (Rx) [Duratocin ( sodium chloride 9 mg) (glacial acetic acid (6–14 mcg) (water
for injection ){01}]

Butorphanol (injection)
Generic Name: butorphanol (injection) (byoo TOR fa nole)
Brand Name: Stadol

What is butorphanol?
 Butorphanol is an opioid pain medication. An opioid is sometimes called a narcotic.
  Butorphanol is used to treat moderate to severe pain. It is also used as part of anesthesia
for surgery, or during early labor (if childbirth is expected to be more than 4 hours away).
 Butorphanol may also be used for purposes not listed in this medication guide.

How is butorphanol given?

 Butorphanol is injected into a muscle or into a vein through an IV. You may be shown how
to use injections at home. Do not give yourself this medicine if you do not understand how
to use the injection and properly dispose of needles, IV tubing, and other items used.

 Follow all directions on your prescription label. Butorphanol can slow or stop your
breathing. Never use butorphanol in larger amounts, or for longer than prescribed. Tell
your doctor if the medicine seems to stop working as well in relieving your pain.
 Butorphanol may be habit-forming, even at regular doses. Never share this medicine with
another person, especially someone with a history of drug abuse or addiction. MISUSE OF
NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child
or other person using the medicine without a prescription. Selling or giving away
butorphanol is against the law.
 Use a disposable needle and syringe only once. Follow any state or local laws about
throwing away used needles and syringes. Use a puncture-proof "sharps" disposal
container (ask your pharmacist where to get one and how to throw it away). Keep this
container out of the reach of children and pets.
 Do not stop using butorphanol suddenly after long-term use, or you could have unpleasant
withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop
using butorphanol.
 Store butorphanol at room temperature away from moisture and heat.
 Do not keep leftover opioid medication. Just one dose can cause death in someone using
this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-
back disposal program. If there is no take-back program, flush the unused medicine down
the toilet.

Butorphanol side effects

 Get emergency medical help if you have signs of an allergic reaction: hives; difficulty
breathing; swelling of your face, lips, tongue, or throat.
 Like other narcotic medicines, butorphanol can slow your breathing. Death may occur if
breathing becomes too weak. A person caring for you should seek emergency medical
attention if you have slow breathing with long pauses, blue colored lips, or if you are hard
to wake up.

Call your doctor at once if you have:

 noisy breathing, sighing, shallow breathing;

 a slow heart rate or weak pulse;
 fast or pounding heartbeats;
 problems with urination;
 a light-headed feeling, like you might pass out; or
 confusion, feeling like you are floating.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as:
agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching,
loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight,
malnourished, or debilitated.

Common side effects include:

 nausea, vomiting;  drowsiness, dizziness;

  dry mouth; or  warmth or redness under the skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical
advice about side effects.

Butorphanol Pregnancy Warnings

Reproduction studies in mice, rats, and rabbits during organogenesis have not revealed evidence
of teratogenicity, however, rats receiving butorphanol 1 mg/kg had a higher frequency of
stillbirths than controls and rabbits receiving oral doses of 30 and 60 mg/kg showed higher
incidences of post implantation loss. Prolonged use of opioid analgesics during pregnancy may
cause neonatal opioid withdrawal syndrome. This drug is not recommended for use during or
immediately prior to labor, when other analgesic techniques are more appropriate. There are no
controlled data in human pregnancy. Chronic opioid use may cause reduced fertility in males and
females; it is unknown whether these effects on fertility are reversible. US FDA pregnancy
category C: Animal reproduction studies have shown an adverse effect on the fetus and there are
no adequate and well-controlled studies in humans, but potential benefits may warrant use of
the drug in pregnant women despite potential risks.Benefit should outweigh risk

US FDA pregnancy category: C

Comments:
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate;
women should be advised of the risk of neonatal abstinence syndrome and ensure that
appropriate treatment will be available.

Butorphanol Breastfeeding small amounts. It is poorly absorbed (adult oral bioavailability is

estimated at 17%) so it is unlikely to adversely affect the breastfed infant. However, there is
limited published data with repeated, high, IV or intranasal doses in breastfed infants. If used,
extra Warnings
This drug is excreted into breastmilk in caution is advised in newborn or preterm infants.
Benefit should outweigh risk
Excreted into human milk: Yes Comment:
-Monitor closely for excess sedation, breathing difficulties, or limpness; mothers should be
instructed to seek immediate medical care if these signs develop.

Tranexamic Acid Tablets

Generic Name: Tranexamic Acid Tablets (TRAN ex AM ik AS id)
Brand Name: Lysteda

Uses of Tranexamic Acid Tablets:

 It is used to treat heavy bleeding during monthly periods (menstruation).
 It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Tranexamic Acid Tablets?

 If you have an allergy to tranexamic acid or any other part of this medicine (tranexamic
acid tablets).
 If you are allergic to any drugs like this one, any other drugs, foods, or other substances.
Tell your doctor about the allergy and what signs you had, like rash; hives; itching;
shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other
signs.
 If you have a blood clot, have ever had a blood clot, or have been told you are at risk of
getting a blood clot.
 If you have any of these health problems: Bleeding in the brain or trouble seeing some
colors.
 If you are taking any of these drugs: Factor IX complex or anti-inhibitor coagulant complex.
 If you are using a hormone-based birth control.
What are some things I need to know or do while I take Tranexamic Acid Tablets?

 Tell all of your health care providers that you take this medicine (tranexamic acid tablets).
This includes your doctors, nurses, pharmacists, and dentists.
 Avoid driving and doing other tasks or actions that call for you to be alert until you see
how this medicine (tranexamic acid tablets) affects you.
 Blood clots have happened with this medicine (tranexamic acid tablets). Tell your doctor if
you have ever had a blood clot. Talk with your doctor.
 Have an eye exam as you have been told by your doctor.
 If you still have heavy periods (menstrual bleeding) after 2 cycles or if this medicine
(tranexamic acid tablets) stops working, talk with your doctor.
 Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about
the benefits and risks of using this medicine (tranexamic acid tablets) while you are
pregnant.
 Tell your doctor if you are breast-feeding. You will need to talk about any risks to your
baby.

How is this medicine (Tranexamic Acid Tablets) best taken?

 Use this medicine (tranexamic acid tablets) as ordered by your doctor. Read all information
given to you. Follow all instructions closely.
 Take with or without food.
 Swallow whole. Do not chew, break, or crush.
 Do not take this medicine (tranexamic acid tablets) for longer than you were told by your
doctor.
 Do not take if you do not have your period.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and
sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right
away if you have any of the following signs or symptoms that may be related to a very bad side
effect:

 Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin
with or without fever; wheezing; tightness in the chest or throat; trouble breathing,
swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or
throat.
 Flushing.
 Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping
on one side of the face, or blurred eyesight.
 Very bad headache.
 Change in eyesight, eye pain, or very bad eye irritation.
 Feeling very tired or weak.
 Seizures.
 Call your doctor right away if you have signs of a blood clot like chest pain or pressure;
coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or
pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Tranexamic Acid Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor
side effects. Call your doctor or get medical help if any of these side effects or any other side
effects bother you or do not go away:
 Headache.  Back pain.
 Belly pain.  Muscle or joint pain.
  Nose stuffiness.  Feeling tired or weak.
 Muscle cramps.
These are not all of the side effects that may occur. If you have questions about side effects, call
your doctor. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:
 If you think there has been an overdose, call your poison control center or get medical
care right away. Be ready to tell or show what was taken, how much, and when it
happened.

Tranexamic acid Pregnancy Warnings

 Animal studies have not shown evidence of an increased occurrence of fetal damage.
There are no controlled data in human pregnancy however tranexamic acid is known to
cross the placenta and appears in cord blood at concentrations approximately equal to
maternal concentration.
 FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk
to the fetus and there are no adequate and well-controlled studies in pregnant women.
 Cyklokapron(R) is only recommended for use during pregnancy when benefit outweighs
risk.
 Lysteda(R) is not indicated for use in pregnant women.

Tranexamic acid Breastfeeding Warnings

 Tranexamic acid should be used during lactation only if clearly needed.

 Excreted into human milk: Yes
 Excreted into animal milk: Data not available
 The effects in the nursing infant are unknown.
 Tranexamic acid is excreted into human milk at a concentration of about one hundredth of
the corresponding serum concentrations

Magnesium Sulfate

Patient Education

What is this drug used for?

Injection: • It is used to treat constipation.
• It is used to treat or prevent low Granules used as soaks:
magnesium levels. • It is used to treat minor sprains or bruises.
• It is used to prevent and control seizures All products:
during pregnancy. • It may be given to you for other reasons.
Granules used by mouth: Talk with the doctor.

IV: Initial: 4 to 6 g loading dose over 20 to 30 minutes, followed by 1 to 2 g/hour continuous

infusion for at least 24 hours after delivery (ACOG 2013; ACOG 202 2019).
IM: Initial: 10 g loading dose administered as 5 g IM in each buttock, then 5 g every 4 hours.
Note: Use IM route when unable to establish venous access (ACOG 202 2019).
Manufacturer's labeling: IV, IM: An initial total dose of 10 to 14 g administered as follows: 4 g
IV infusion with simultaneous IM injections of 4 to 5 g in each buttock. After the initial IV/IM
doses, may administer a 1 to 2 g/hour continuous infusion or may follow with IM doses of 4 to 5 g
into alternate buttocks every 4 hours as necessary.
Hypomagnesemia, treatment: Note: Treatment depends on severity and clinical status. In
asymptomatic patients (when oral route is available), oral replacement therapy is a better
replacement method than IV administration.
Mild deficiency: IM: 1 g every 6 hours for 4 doses, or as indicated by serum magnesium
concentrations
Mild to moderate (serum concentration 1 to 1.5 mg/dL): IV: 1 to 4 g (up to 0.125 g/kg),
administer at ≤1 g/hour if asymptomatic; do not exceed 12 g over 12 hours (Kraft 2005). Note:
Additional supplementation may be required after the initial dose with replenishment occurring
over several days.
Warnings/Precautions

Disease-related concerns:
• Neuromuscular disease: Use with extreme caution in patients with myasthenia gravis or other
neuromuscular disease.
• Renal impairment: Use with caution in patients with renal impairment; accumulation of
magnesium may lead to magnesium intoxication.

Other side effects of this drug: Talk with your doctor right away if you have any of
these signs of:

•
High magnesium levels like confusion, • Sweating a lot
feeling sluggish, slow movements, shortness • Flushing
of breath, nausea, severe dizziness, or • Difficulty moving
passing out. • Severe diarrhea
• Low calcium like muscle cramps or spasms, • Severe nausea
numbness and tingling, or seizures. • Severe vomiting
• Abnormal heartbeat • Black, tarry, or bloody stools
• Sensation of cold • Cramps
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever;
itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note:
This is not a comprehensive list of all side effects. Patient should consult prescriber for additional
questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is
intended to serve as a concise initial reference for health care professionals to use when
discussing medications with a patient. You must ultimately rely on your own discretion,
experience, and judgment in diagnosing, treating, and advising patients.

Hydralazine Injection
Generic Name: Hydralazine Injection (hye DRAL a zeen)
Hydralazine, sold under the brand name Apresoline among others, is a medication used to treat
high blood pressure and heart failure. This includes high blood pressure in pregnancy and very
high blood pressure resulting in symptoms. Hydralazine is used with or without other medications
to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks,
and kidney problems. Hydralazine is called a vasodilator. It works by relaxing blood vessels so
blood can flow through the body more easily.

What do I need to tell my doctor BEFORE I take Hydralazine Injection?

 If you have an allergy to hydralazine or any other part of hydralazine injection.

 If you are allergic to any drugs like this one, any other drugs, foods, or other substances.
Tell your doctor about the allergy and what signs you had, like rash; hives; itching;
shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other
signs.
 If you have rheumatic heart disease that affected a heart valve.
 If you have heart disease, talk with your doctor.
This is not a list of all drugs or health problems that interact with hydralazine injection.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products,
vitamins) and health problems. You must check to make sure that it is safe for you to take
hydralazine injection with all of your drugs and health problems. Do not start, stop, or change the
dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Hydralazine Injection?

 Tell all of your health care providers that you take hydralazine injection. This includes your
doctors, nurses, pharmacists, and dentists.
  Avoid driving and doing other tasks or actions that call for you to be alert until you see
how hydralazine injection affects you.
 To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or
lying down. Be careful going up and down stairs.
 Have your blood pressure checked often. Talk with your doctor.
 Have your blood work checked if you are on hydralazine injection for a long time. Talk with
your doctor.
 Talk with your doctor before using OTC products that may raise blood pressure. These
include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some
natural products or aids.
 Talk with your doctor before you drink alcohol.
 Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You
will need to talk about the benefits and risks to you and the baby.
 How is this medicine (Hydralazine Injection) best taken?
 Use hydralazine injection as ordered by your doctor. Read all information given to you.
Follow all instructions closely.
 It is given as a shot into a muscle or vein.

What are some side effects that I need to call my doctor about right away?
 WARNING/CAUTION: Even though it may be rare, some people may have very bad and
sometimes deadly side effects when taking a drug. Tell your doctor or get medical help
right away if you have any of the following signs or symptoms that may be related to a
very bad side effect:

 Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin
with or without fever; wheezing; tightness in the chest or throat; trouble breathing,
swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or
throat.
 Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint
pain, chest pain or shortness of breath, or swelling in the arms or legs.
 Not able to pass urine or change in how much urine is passed.
 Very bad dizziness or passing out.
 Chest pain or pressure.
 Fast or abnormal heartbeat.
 A burning, numbness, or tingling feeling that is not normal.
 Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or
weak.

What are some other side effects of Hydralazine Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor
side effects. Call your doctor or get medical help if any of these side effects or any other side
effects bother you or do not go away:
 Headache.  Not hungry.
 Diarrhea.  Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call
your doctor. Call your doctor for medical advice about side effects.

Hydralazine Pregnancy Warnings

 Use should be avoided during the first two trimesters of pregnancy; use is not
recommended during the third trimester unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C

US FDA pregnancy category: C
Hydralazine Breastfeeding Warnings
During the first week postpartum, 10 lactating women had blood and breast milk samples
analyzed 24 hours after receiving a dose between 10 and 40 mg. The average concentration of
this drug plus its pharmacologically active acid-labile metabolites in breast milk was 240 nmol/L
(about half of the simultaneous concentration in maternal plasma). It was further estimated that
the daily dose to a breastfed infant was unlikely to exceed 25 mcg. Serum drug concentrations
were measured in 2 infants 2 hours after feeding in this study and were determined to be 557
and 293 nmol/L.
Use is considered acceptable; according to some experts, use only if the benefit outweighs the
potential risk.
Excreted into human milk: Yes
Comments: This drug has been used without apparent harmful effects in the nursing infant.