MAKENA- Hydroxyprogesterone-Caprogesterone Administration - DailyMed
Not all of these features contain all the information necessary to use MAKENA securely and efficiently. For complete prescription information, see MAKENA. Macena is a gestagen indicated to decrease the risks of premature delivery in pregnant singlet woman with a prehistory of premature delivery (1). Makena's efficacy is due to the improved percentage of pregnant woman who showed < 37 gestational phases (14).
In order to register an ADVERSE REACTION, please call AMAG Pharmaceuticals at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. It is a gestagen indicated to decrease the risks of premature delivery in pregnant singlet woman who have a prehistory of premature delivery. Makena's efficacy is due to the improved percentage of pregnant woman who showed < 37week.
Whereas there are many premature baby risks, the effectiveness and reliability of Makena has only been proven in females with a previous premature singlet-on. Do not use in the case of premature babies with more than one baby or other premature deaths. The Makena is a clear, yet colourful answer.
The Makena one or more dosage bottles are only intended for intra-muscular injections with a shot into the top external quadrants of the gluteal muscle, whereby the site of injections is turned to the other side of the preceding weeks by the following preparatory and delivery procedure: We recommend a gradual injections (more than one min or longer).
Pressing the injected site minimizes squeezing and swollenness. The Makena autoinjector is a 27 gauges, 0.5 in. needles that deliver a dosage to the back of the humerus undercutaneously. As Makena autoinjector is preservative-free, the unit should be used or disposed of immediately after removing the canopy.
Turn the injected site onto the replacement sleeve of the preceding one. Autoinjector will take about 15 seconds to dispense the dosage; if the viewport is fully obstructed (fully orange), the full dosage has been used. The" Instructions for Use" contain details of how to administer the hypodermic injections with the autoinjector[see Dosage and administration (2.3)].
Please thoroughly reread the "Instructions for Use" before you administer the Makena autoinjector. Subsection: 275 mg/1. 1 mL clear gel in disposable autoinjector. intra-muscular injection: 250 mg/ml clear gel vials. intra-muscular injection: 1,250 mg/5 mL ( "250 mg/mL") clear gel in multi-can bottles. Don't use Makena on a woman with any of the following conditions:
Interrupt Makena if an arterial or profound phlebbotic or thrombolytic episode appears. Allergy responses, include hives, pruritis and angioedema, have been described with Makena or other substances containing casteroil. Watch predibabetic and diabetic females closely while they receive Makena. Since progestin medicines can cause a certain level of liquid retentions, you should closely watch patients with diseases that could be affected by this effect (e.g. pre-eclampsia, seizures, migraines, asthma, heart or kidney dysfunction).
Watch a woman who has a clinical blues history and stop Makena if the blues recur. Watch closely those who may experience icterus while taking Makena and see if the benefits of using it warrant it. Watch your health care professional for high blood pressure while taking Makena and see if the benefits of taking it are worth continuing.
On the most serious side effects of progestin use, see Warnings and precautions (5). However, because studies are carried out under very different circumstances, the side effect rate seen in the studies of one medicine cannot be directly comparable to the rate seen in the studies of another medicine and may not mirror the rate seen in use.
In the Makena patients, certain pregnancy-related foetal and maternal complications or incidents were elevated in numerical order in comparison to controls, which included miscarriages and stillbirths, premature birth, pre-eclampsia or high pressure, gestation syndrome and oligohydramnion (Tables 1 and 2). Frequent unwanted reactions: Intra-muscular injections were most frequently associated with site pains after at least one of 34 injections.
8 percent of the Makena Group and 32. In the Makena group with a higher incidence than in the controls, the side effects were found in 2% of the population. Twenty-two percent of the topics that Makena receives were referred in the study using IV injections as discontinutive therapies due to adverse responses compromised with 2. 6 percent of controls.
In both groups, the most frequent side effects leading to abortion were hives and pain/swellings at the site of infection (1% each). Lung embolism in one patient and cellulite at the site of injecting in another patient were recorded as serious side effects in Makena-treated patients. In the past, two trials were performed on postmenopausal menopausally well behaved postmenopausal girls, where Makena was compared via a hypodermic autoinjector with Makena as intra-muscular intrainject.
During the first trial, 3/30 (10%) of those who used the hypodermic autoinjector experienced site discomfort 2/30 (7%) of those who received IV injections. 20/59 (34%) of patients using the hypodermic autoinjector in the second trial experienced site discomfort compared to 5/61 (8%) of patients who received IV.
Subsequent side effects were observed when Makena was used after approval. In-vitro trials on the interplay of drugs were carried out with Makena. Hydroxy-progesterone capsroate has minimum toxicity for co-administered drugs related to C1A2, C2A6 and 2b6 in these levels. In-vitro results showed that the therapeutical level of hydroxy-progesterone capsorate probably does not block the activities of CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4[See clinical pharmacology (12.3)].
It is indicated to decrease the risks of premature delivery in single-ton pregnant mothers who have a previous single-ton sponge delivery. Figures from the placebo-controlled and the babyafety studies [see clinics (14. 1, 14. 2)] showed no differences in the negative development results between infants of Makena-treated females and infants of mammals.
These figures, however, are not sufficient to identify a drug-related health hazard for undesirable development results, as none of the patients receiving Makena were given the medication in the first quarter of conception. Animals reproductive trials did not associate inferior development results with intra-muscular application of hydroxy progesterone capsroate to gestational pregnancies in dosages equal to five multiples of the man average dosage of 60 kg humans.
For the US public, the assessed risks of serious congenital errors and miscarriages in hospitalized maternity are 2% to 4% and 15% to 20%, respectively. Reproductive trials of hydrocrogesterone capsroate in various animals have been published. The embryo ethality in embryo typhus exercised hydroxy progesterone capsroate was recorded up to 2. 4 and 24 fold the HRC, but not in monkey exercised hydroxy progesterone capsroate in 2. 4 fold the HRC, every 7 day between 20 and 146 dígd. of pregnancy.
Reproductive trials have been conducted in up to 95 and 5 times the normal dosage of the mouse and rat, respectively, and have shown no signs of impairment of fertility or damage to the foetus by hydroxy progesterone caproates. Small amounts of gestagens are present in drinking water using progesterone containing substances, incl. hydroxy progesterone-caproates.
Previously publicised trials have shown no negative impact of progestogens on the breastfeeding baby or dairy cows. The Makena is not suitable for under-16s. In a small number of females under 18 years of age it is estimated that female 16 years of age or over have the same level of security and effectiveness as those 18 years of age and older [See Clinical trials (14)].
There have been no pharmacokinetic investigations of Makena in liver dysfunction outcomes. It is largely metabolised and healing disorders can help to eliminate Makena. An overdose of Makena has not been reported in recent medical research. In Makena, the pharmaceutically agent is hydroxy progesterone capsroate, a butane.
A pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy] is the term used for hydroxypropyl esterone captor. The caprogates are available as either pure or virtually pure quartz crystal or powders with a smelting point of 120°-124°C. Macena is a clear, amber, aseptic, non-pyrogenic medical device for injecting into the muscles (vials) or subcutaneously (autoinjector). A 1 mL Makena autoinjector for hypodermic application and 1 mL single-dose bottles each for intensive muscular application contains Hydroxyprogesteron-Caprogesterone USP, 250 mg/ml (25% w/v), in a preservative-free USP ricinus oleic acid sol.
Every 5 mL multidose bottle contains 250 mg/ml (25% w/v) of USP hydroxy progesterone caprogesterone, USP 28.6% of USP casting grade and 46% v/v of USP benzylbenzoate with NF 2% v/v benzene as preservatives. Respiratory progesterone capsroate is a synthesized progestogen. There is no known mechanisms by which hydroxy-progesterone capsroate can reduce the chance of recurring premature delivery.
There were no pharmaco-dynamic trials with Makena. Females with a single motherhood were given 250 mg fluoride progesterone caproates to reduce premature delivery from 16 to 20 week 0 to 6-day. In all three groups, the maximum concentrations (Cmax) and the area under the graph (AUC(1-7 days)) of the monohydroxylated metabolite were about 3-8 times lower than the corresponding parameter for the initial medicine hydroxy-progesterone capsorate.
Excretion half-life of hydroxy-progesterone caproates, as assessed by 4 subjects in the trial who had achieved full pregnancy duration, was 16. Subcutaneous macena with the autoinjector (1.1 mL) in the posterior part of the humerus and macena intramuscular ( 1 mL) in the superior external quadrants of the gluteal muscle were observed in a randomised, concomitant postmenopausal trial of 120 normal postmenopausal females with a similar level of hydroxypropgesterone caproat in a single-dose, open-label, randomised, concomitant designed bio-availability.
Hydroxy-progesterone capsroate largely bind to plasmaproteins which include alumin and corticosteroid-binding globulin. In vitro trials have shown that hydroxy progesterone caproates can be metabolised by humans through both Phases I and II responses. Hydroxy-progesterone caproat is strongly reduced, hydroxylated and conjugated. In-vitro results show that the metabolic activity of hydroxy-progesterone caproates is predominantly conveyed by CYP3A4 and in vitro progesterone capro.
In vitro results show that the caproates group is maintained during the hydroxypropgesterone caproation process. Approximately 50% of a dosage was regained in stool and 30% in pee after 10-12 week pregnancy after administering intramuscularly to expectant mother. In vitro inhibitory studies with humans living cell mice and CYP source selected substrate showed that hydroxy-progesterone caproates raised the conversion rates of the metabolites C4P1A2, C4P2A6 and C4P2B6 by about 80%, 150% and 80%, respectively.
In another in vitro trial of humans in which the prototype inductors or blockers induced or inhibited the expected increase or decrease in CYP enzymatic activites, induced or inhibited hydroxy progesterone caproates not the active ingredient C4P1A2 -, C4P2A6 or C4P2B6. Overall, the results suggest that hydroxy-progesterone caprogates have a minimum level of clinical relevance for the levels of C1A2, C2A6 and C2B6.
In-vitro results showed that the therapeutical level of hydroxy-progesterone capsroate is unlikely to block the activities of CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. The test for carcinogenity of hydroxy progesterone capsroate was insufficient. The intramuscular administration of hydroxy progesterone capsroate had no negative effect on mothers (F0), their evolving progeny (F1) or the capacity of these progeny to generate a viable, healthy second family ( (F2) at pregnancy exposure up to 5 x the suggested mortality rate.
A multicentre, randomised, double-blind, placebo-controlled study investigated the efficacy and efficacy of Makena in reducing the risks of miscarriage in single pregnant mothers ( (ages 16 to 43 years) who had a recorded past experience of miscarriage (defined as childbirth in less than 37 gestational cycles after miscarriage or early membrane rupture).
Females were ruled out for previous treatments with progressive steron or haeparin during the present period of gestational age, a previous medical record of thrombo-embolic illness or maternal/obstetric problems (such as present or proposed cerclages, drug-related hyper-pressure or an attack disorder). In all, 463 pregant females were randomly selected to obtain either Makena (N=310) or Vehikel (N=153) in a 250 mg daily dosage given by IV injections, which lasts between 16 wks, 0 day and 20 wks, 6 day of impregnation and up to 37 that.
The demography of Makena-treated females was similar to that of the reference group and included: Table 5 shows the percentage of females in each of the arms who gave birth at < 37 (the main end point of the study), < 35 and < 32 pregnancy week. In comparison to the checks, Makena therapy decreased the percentage of prematurely giving birth to < 37week-olds.
Females who provided < 35 and < 32-week regimens were also lower among those receiving Makena. The number of premature babies was restricted to < 32 in comparison with the other gestation years. Following the adjustment for period in the trial, 7. 5% of Makena-treated topics supplied 25 Weeks ago versus 4. 7% of controls; see Fig. 1.
Because of the higher rates of miscarriage and stillbirth in the Makena branch, no overall survivor differences could be detected in this CL. An aggregate neonal morbidity/mortality index assessed negative results in living birth. Though the percentage of newborns who suffered 1 or more incidents was lower in the Makena branch (11. 9% vs. 17. 2%), the number of detrimental results was marginal and the gap between poor was not statistical significant.
Babies borne by females admitted to this trial who lived to be released from the manger were able to participate in another one. Ninety-nine hundred and 194 offspring of Makena-treated wives and 84 offspring of controls. The Makena autoinjector (NDC 64011-301-03) is delivered as 1.1 mL of a clear amber, aseptic, preservative-free liquid in an auto-injector with prefilled spray.
The 1 mL autoinjector contains USP hydroxy progesterone caprogesterone, 250 mg/mL (25% w/v), USP casting resin and USP benzoate in 30-6% v/v and 46% v/v benzylbenzoates. Embalming 1 mL Makena autoinjector with 275 mg hydroxy progesterone capsor. Do not expose the auto-injector to sunlight. Keep the autoinjector in its carton. Macena (NDC 64011-247-02) is delivered as 1 mL of a clean, clear, neutral, clear gel in one ampoule.
Every 1 mL ampoule contains USP hydroxy progesterone caprogesterone, 250 mg/mL (25% w/v), USP casting resin and USP benzyl benzate (46% v/v). Includes 1 mL of Makena ampoule with 250 mg of hydroxy progesterone capsod. Macena (NDC 64011-243-01) is delivered as 5 mL of a clear, transparent, yellow liquid in a multi-dose bottle.
Every 5 mL ampoule contains USP 250 mg/ml (25% w/v) of hydroxy progesterone caprogesterone in USP 28.6% v/v and USP 46% v/v of benzylbenzoate with the NF 2% v/v benzenecol. Includes a 5 mL multi-dose bottle of Makena (250 mg/ml) with 1250 mg hydroxy progesterone capsor. Advise the patient that Makena injection can cause pains, aches, swellings, pruritus or bruises.
Tell the doctor if the symptoms, accumulation of bleeding or fluids or inflammatory reaction at the site of infection increase over time[see side effects (6.1)]. Every mL contains: hydroxy progesterone caproat 250 mg, benzylbenzoate 46%, ricinus and 28. Ingredients: 1 mL: hydroxy progesterone caproat 250 mg, benzylbenzoate 46% and ricinus 31%.
ONLY FOR HYPODERMIC INJECTIONS. ONLY FOR HYPODERMIC INJECTIONS. Check that the screen is fully reddish-brown before you remove it from the site of inject.