Ossitocina

Ossitocina (sold as Ossitocina, Ossitocina) is a mammalian hormone that also acts as a neurotransmitter in the brain.

It is best known for its roles in female reproduction: it is released in large amounts after distension of the cervix and vagina during labor, and after stimulation of the nipples, facilitating birth and breastfeeding, respectively. Recent studies have begun to investigate Ossitocina's role in various behaviors, including orgasm, social recognition, pair bonding, anxiety, trust, love, and maternal behaviors.

Nasal

Facilitate lactation

Adult: 1 spray (4 units) into 1 nostril 5 minutes before suckling.

Incompatibility: When admixed: fibrinolysin (human), norepinephrine, prochlorperazine edisylate, warfarin; variable compatibility with phytonadione.

Intravenous

Adjunct in abortion

Adult: 10-20 milliunits/minute. Max total dose: 30 units in a 12-hr period.

Reconstitution: Ossitocina 10 units to 500 ml of a physiologic saline solution or glucose 5%.

Incompatibility: When admixed: fibrinolysin (human), norepinephrine, prochlorperazine edisylate, warfarin; variable compatibility with phytonadione.

Intravenous

Postpartum haemorrhage

Adult: 10-40 units by infusion in 1000 mL of IV fluid at a rate sufficient to control uterine atony.

Reconstitution: Postpartum uterine bleeding: Ossitocina 10-40 units to running IV infusion, max 40 units/1000 ml.

Incompatibility: When admixed: fibrinolysin (human), norepinephrine, prochlorperazine edisylate, warfarin; variable compatibility with phytonadione.

Intravenous

Labour induction

Adult: 1-2 milliunits/minute, may increase at intervals of at least 30 minutes until a max of 3-4 contractions occur every 10 minutes. Not to exceed 32 milliunits/minute and no more than a total of 5 units should be given in 1 day. Not to be given within 6 hr after admin of vaginal prostaglandins. Monitor uterine contractions and foetal heart rate continuously. Withdraw gradually once labour is progressing.

Reconstitution: Ossitocina 10 units to 500-1000 ml normal saline or lactated Ringer's to produce a solution of 10 milliunits/ml, rotate solution to mix. Normally infused at 3 ml/hr (delivering 0.001 unit/min). For higher doses: Ossitocina 30 units can be added to 500 ml of diluent and infused at 1 ml/hr (delivering 0.001 unit/min).

Incompatibility: When admixed: fibrinolysin (human), norepinephrine, prochlorperazine edisylate, warfarin; variable compatibility with phytonadione.

Intravenous

Ossitocina challenge test for evaluating of foetal distress

Adult: Dilute 5-10 units in 1 L of 5% dextrose inj. Initially, administer the drug in the mother via IV infusion at a rate of 0.5 milliunits/minute. May gradually increase infusion rate at intervals of 15-30 minutes. Max: 20 milliunits/minute. Monitor foetal heart rate and uterine contractions immediately before and during infusion. Discontinue infusion when 3 moderate uterine contractions occur within one 10-minute interval. Compare baseline and Ossitocina-induced foetal heart rates. If no change occurs, repeat the test in 1 wk. Termination of pregnancy may be required if a late deceleration in foetal heart rate occurs.

Ossitocina is a hormone used to help start or continue labor and to control bleeding after delivery. It is also sometimes used to help milk secretion in breast-feeding.

Ossitocina may also be used for other conditions as determined by your doctor.

In general, Ossitocina should not be used to start labor unless there are specific medical reasons. Be sure you have discussed this with your doctor before receiving Ossitocina.

Ossitocina is available only with your doctor's prescription.

Novartis Pharmaceuticals removed Ossitocina® nasal spray from the market in March 1995.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Ossitocina is used in certain patients for the following:

• Testing the ability of the placenta to support a pregnancy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The dosage of Ossitocina 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 Ossitocina 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 Ossitocina infusion on a physiologic electrolyte solution, permitting the Ossitocina infusion to be stopped abruptly without interrupting the electrolyte infusion. This is done in the following way.

Preparation

1. The standard solution for infusion of Ossitocina is prepared by adding the contents of one 1-mL vial containing 10 units of Ossitocina to 1000 mL of 0.9% aqueous sodium chloride or Ringer's lactate. The combined solution containing 10 milliunits (mU) of Ossitocina/mL is rotated in the infusion bottle for thorough mixing.
2. Establish the infusion with a separate bottle of physiologic electrolyte solution not containing Ossitocina.
3. Attach (piggyback) the Ossitocina-containing bottle with the infusion pump to the infusion line as close to the infusion site as possible.

Administration

The initial dose should be 0.5–1 mU/min (equal to 3–6 mL of the dilute Ossitocina solution per hour). At 30–60 minute intervals the dose should be gradually increased in increments of 1–2 mU/min until the desired contraction pattern has been established. Once the desired frequency of contractions has been reached and labor has progressed to 5–6 cm dilation, the dose may be reduced by similar increments.

Studies of the concentrations of Ossitocina in the maternal plasma during Ossitocina infusion have shown that infusion rates up to 6 mU/min give the same Ossitocina levels that are found in spontaneous labor. At term, higher infusion rates should be given with great care, and rates exceeding 9–10 mU/min are rarely required. Before term, when the sensitivity of the uterus is lower because of a lower concentration of Ossitocina receptors, a higher infusion rate may be required.

Monitoring

1. Electronically monitor the uterine activity and the fetal heart rate throughout the infusion of Ossitocina. Attention should be given to tonus, amplitude and frequency of contractions, and to the fetal heart rate in relation to uterine contractions. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.
2. Discontinue the infusion of Ossitocina immediately in the event of uterine hyperactivity and/or fetal distress. Administer oxygen to the mother, who preferably should be put in a lateral position. The condition of mother and fetus should immediately be evaluated by the responsible physician and appropriate steps taken.

Control of Postpartum Uterine Bleeding

1. Intravenous infusion (drip method). If the patient has an intravenous infusion running, 10 to 40 units of Ossitocina may be added to the bottle, depending on the amount of electrolyte or dextrose solution remaining (maximum 40 units to 1000 mL). Adjust the infusion rate to sustain uterine contraction and control uterine atony.

2. Intramuscular administration. (One mL) Ten (10) units of Ossitocina can be given after the delivery of the placenta.

Treatment Of Incomplete, Inevitable, Or Elective Abortion

Intravenous infusion of 10 units of Ossitocina added to 500 mL of a physiologic saline solution or 5% dextrose-in-water solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable, or elective abortion.

Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc., for midtrimester elective abortion, the injection-to-abortion time may be shortened by infusion of Ossitocina at the rate of 10 to 20 milliunits (20 to 40 drops) per minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.

How supplied

Ossitocina (Ossitocina Injection, USP) Synthetic is available as follows:

NDC 42023-116-25 Packages of twenty-five oversized 1-mL vials, each containing 10 units of Ossitocina.

NDC 42023-116-01 A 10 mL multiple-dose vial containing 10 units of Ossitocina per mL (total = 100 units of Ossitocina).

NDC 42023-116-02 Packages of twenty-five 10 mL multiple-dose vial, each containing 10 units of Ossitocina per mL (total = 100 units of Ossitocina per vial).

Storage

Store between 20° to 25°C (68° to 77°F).

REFERENCES

1. Seitchik J, Castillo M: Ossitocina augmentation of dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899–905.

Manufacturer details: n/a

See also:
What is the most important information I should know about Ossitocina?

You should not receive this medication if you have ever had an allergic reaction to Ossitocina.

Before you receive Ossitocina, tell your caregivers if you have genital herpes, diabetes, high blood pressure, a heart rhythm disorder, or if you have ever had cervical cancer, a severe uterine infection, or surgery (including a C-section) on your cervix or uterus. Also tell your caregivers if you have ever had difficult labor because you have a small pelvis, if your pregnancy is less than 37 weeks, or if you have had 5 or more pregnancies.

Tell your doctor about all other medicines you use, especially cough or cold medicine, medicines that contain caffeine (such as migraine headache medicine), or a stimulant such as ADHD medication.

Use Ossitocina as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ossitocina is usually administered as an infusion at you doctor's office, hospital, or clinic.
• If Ossitocina contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Ossitocina, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ossitocina.

Use: Labeled Indications

Antepartum: Induction of labor in patients with a medical indication (eg, Rh problems, maternal diabetes, preeclampsia, at or near term); stimulation or reinforcement of labor (as in selected cases of uterine inertia); adjunctive therapy in management of incomplete or inevitable abortion

Postpartum: To produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

See also:
What other drugs will affect Ossitocina?

Carboprost Tromethamine: May enhance the adverse/toxic effect of Oxytocic Agents. Specifically, oxytocic effects may be enhanced. Avoid combination

Dinoprostone: May enhance the adverse/toxic effect of Ossitocina. Specifically, oxytocic effects may be enhanced. Management: Concomitant use of dinoprostone and Ossitocina is not recommended. If used sequentially, monitor uterine activity closely. Administer Ossitocina 30 minutes after removing dinoprostone vaginal insert and 6 to 12 hours after the application of dinoprostone gel. Consider therapy modification

EPHEDrine (Nasal): Ossitocina may enhance the hypertensive effect of EPHEDrine (Nasal). Monitor therapy

EPHEDrine (Systemic): Ossitocina may enhance the hypertensive effect of EPHEDrine (Systemic). Monitor therapy

Gemeprost: May enhance the adverse/toxic effect of Ossitocina. Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

MiSOPROStol: May enhance the adverse/toxic effect of Ossitocina. Specifically, oxytocic effects may be enhanced. Management: The manufacturer of misoprostol recommends avoiding concomitant use with Ossitocina. Misoprostol may augment effects of Ossitocina, particularly when given within 4 hours of Ossitocina initiation. Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

See also:
What are the possible side effects of Ossitocina?

Applies to Ossitocina: solution

As well as its needed effects, Ossitocina (the active ingredient contained in Ossitocina) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking Ossitocina, check with your doctor or nurse immediately:

Rare

• Confusion
• convulsions (seizures)
• difficulty in breathing
• dizziness
• fast or irregular heartbeat
• headache (continuing or severe)
• hives
• pelvic or abdominal pain (severe)
• skin rash or itching
• vaginal bleeding (increased or continuing)
• weakness
• weight gain (rapid)

• Abdominal pain or cramping
• blood clotting problem that causes prolonged bleeding
• chest pain or discomfort
• cough
• difficulty swallowing
• extra heartbeats
• fainting
• lightheadedness
• pounding or rapid pulse
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe bleeding after giving birth
• shortness of breath
• tightness in the chest
• unusual tiredness or weakness
• wheezing

If any of the following symptoms of overdose occur while taking Ossitocina, get emergency help immediately:

Symptoms of overdose:

• Restlessness
• shakiness
• sleepiness
• slow to respond
• slurred speech
• unconsciousness

Minor Side Effects

Some Ossitocina side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Rare

• Nausea
• vomiting