Inject Able Contraceptives

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Introduction

Injectable contraceptives
contain hormonal drugs that
provide women with safe,
highly effective, and
reversible contraceptive
protection.
Two types of injectable
contraceptives :
(1) Progestogen-only formulations
that contain a progestogen hormone
and are effective for 2 or 3 months;
and,
(2) Combined formulations that
contain both a progestogen and an
estrogen and are effective for 1
month
Progestogen -only formulations
Consist of DMPA (depot med-
roxyprogesterone acetate) and NET-EN
(norethisterone enanthate).
DMPA is the injectable formulation
most widely used worldwide.
DMPA is injected every 3 months.
NET-EN is injected every 2 months.
Combined formulations
The most extensively studied
formulations are known by their
brand names, Mesigyna;
Monthly injectable.
Mesigyna contains the same
progestogen as NET-EN.&
contains an added estrogen.
Combined formulations
Administered by a deep
intramuscular injection into
the muscle of the arm or
buttock and are effective
immediately, provided they
are taken at specified times
All injectable contraceptives are
slowly absorbed into the
bloodstream from the injection
site, with the body maintaining
a sufficient level of hormone to
provide contraception for 1 to
3 months, depending on the
type of injectable used
Name Active Duration of Common
ingredients effect trade names

DMPA 150 mg
90 days Depo-Provera,
medroxyprogesterone
(progestogen- acetate in an aqueous Depo-Clinovir,
only) microcrystalline

suspension others

NET-EN 200 mg 60 days Noristerat,


norethisterone Norigest,
progestogen)
enanthate
(-only Doryxas, and
in an oily preparation
others

Mesigyna mg 50 30 days Mesigyna,


norethisterone
(combined) enanthate and Norigynon
mg estradiol 5
valerate
PROGESTOGEN
ONLY INJECTABLES
Mode of Action
The immediate action of progestagen-only
injectables )POIs( is to thicken cervical
mucus, which then presents an obstacle to
sperm penetration.
Also, ovulation is impaired.
There are additional changes in the
endometrium that make it unfavourable to
implantation; however, the first two effects
make fertilisation highly unlikely.
Efficacy
The reported failure
rates of POIs are low,
and come within the
narrow range of
0.1% to 0.6%.
Beneficial Effects
Prevention of pregnancy
A single injection of a POI can provide
highly effective protection against
pregnancy for two or more months,
depending on the formulation.
Delivery is simple, independent of coitus,
and ensures periodic contact with medical or
other trained health personnel.
This is a suitable method for women in
whom oestrogens present health risks
eg, those with a history of thromboembolic
disorders - and those who have had side
effects with the use of oestrogens.
Non-contraceptive health benefits

Clear benefits
Sickle cell disease: In a two-year
trial, women with sickle cell disease
using DMPA had significantly fewer
crises than women given a placebo.
Anaemia: POIs can increase
haemoglobin concentration, mainly
by reducing menstrual blood loss.
Non-contraceptive health benefits
Possible benefits
1. Endometrial cancer:
In a World Health Organization (WHO) study, women
who had ever used DMPA had one-fifth the risk of
developing endometrial malignancy observed in
women who had not used DMPA.
The results, although not statistically significant,
support the hypothesis that use of DMPA might
protect against this form of cancer.
2. Other:
The use of POIs possibly protects against pelvic
inflammatory disease (PID), seizures in women with
epilepsy, uterine myoma, and endometriosis.
PROGESTOGEN ONLY
INJECTABLES

SIDE EFFECTS
Menstrual irregularities
DMPA and NET-EN are associated
with disruptions of the menstrual
cycle including amenorrhoea,
prolonged menses, spotting between
periods, and heavy bleeding.
Less than one-third of women
receiving DMPA report having normal
menstrual cycles during the first year
of use.
Menstrual irregularities
Amenorrhoea is the most common
side-effect and its occurrence
increases with duration of use from
about 50 % of DMPA users by the
end of one year to 80% by the end
of 5 years.
Women using NET-EN are less likely
to experience amenorrhoea.
Menstrual irregularities
Heavy bleeding is uncommon (occurs in
1-2% of users), and prolonged bleeding is
seldom heavy enough to be a threat to
health.
Any woman who reports prolonged or
heavy bleeding may need to be
evaluated for anemia.
Anaemia treatments include nutritional
advice & an appropriate dosage of oral
iron tablets.
Menstrual irregularities
Treatments for heavy bleeding include
non-aspirin anti-inflammatory drugs such
as ibuprofen, short-term use of combined
oral contraceptives or estrogen, or early
administration of the next injection (not
sooner than 4 weeks after the previous
injection).
If these measures are not effective or the
womans health is threatened, POIs
should be discontinued.
Other Side-Effects
After menstrual changes, weight gain,
headache, and dizziness are the next most
common side-effects reported.
Most users of POIs put on weight and this is a
common reason for discontinuation.
The average DMPA user gains 1.52.0 kg in
the first year and some users continue to gain
weight thereafter at about the same rate.
In clinical trials, between 3% and 19% of users
of injectables have reported headache or
dizziness. Few women discontinue for these
reasons.
Possible Carcinogenicity
Clinical studies have found no association
between DMPA use and cervical, ovarian, or
liver cancers,
And have confirmed a substantial protective
effect against endometrial cancer.
Studies have found no overall increase in
risk of breast cancer.
Although some studies have indicated a small
increased risk of breast cancer in some younger
women following initial exposure, the studies
show no trend toward increased risk among
more long-term users.
Bone density
Findings to date suggest a relatively small
and reversible effect, with no serious
health risk for women of any age.
At present, medical experts recommend no
restriction on use of injectables by
adolescents over age 16.
Changes in calcium uptake by bone and
decreases in urinary calcium excretion have
been documented and there is a
suggestion of a relation between long
term use of DMPA and low bone mass.
Effect on fetal exposure
There are no known adverse effects of fetal
exposure to injectables.
Studies of teenage children who were exposed
to DMPA in utero show no significant
differences in health, growth, or sexual
development compared to other children.
Progestogen-only injectables can be used by
breastfeeding women at 6 weeks postpartum
without adverse effects on nursing infants.
Effect on Metabolism
The only metabolic effect of undoubted clinical
importance is weight gain.
- Minor alterations of lipid metabolism,
fluid/nitrogen balance, glucose tolerance,
steroid metabolism, and immune function
have been recorded but seem to be of no
clinical significance.
- Fewer data have been published on the
metabolic effects of NET-EN, but its effect on
most biochemical functions appears to be similar
to that of DMPA.
Cardiovascular Effect
Data are insufficient to indicate whether there
is any relation between DMPA use and
cardiovascular complications.
Results of a WHO study suggest that there is
little or no increased risk of cardiovascular
disease associated with the use of
progestagen-only injectables, although further
investigation is needed into a possible
increased risk of stroke among women with
high blood pressure.
RETURN OF FERTILITY
Fertility is not impaired after discontinuation of
DMPA or NET-EN although its return is delayed.
The average time between the last DMPA injection
and conception is about nine months, including the
three months during which the injection is effective.
More than 80% of women become pregnant within
one year of discontinuing DMPA and 90% within
two years.
The few data on NET-EN suggest that fertility
returns more quickly with this agent.
World Health Organization )WHO( developed eligibility
. criteria for the use of various contraceptive methods
Category 1: A condition for which there is no
restriction for the use of the contraceptive method.
Category 2: A condition where the advantages of
using the method generally outweigh the theoretical
or proven risks.
Category 3: A condition where the theoretical or
proven risks usually outweigh the advantages of
using the method.
Category 4: A condition which represents an
unacceptable health risk if the contraceptive method
is used.
Contra-indications
: )category 4(
POIs should not be used in
the presence of:
1. Confirmed or suspected
pregnancy
2. Malignant disease of the
breast
Conditions requiring careful
:consideration )category 3(
POIs should generally not be used in the
presence of:
1. Diabetes with vascular disease or of >20 years
duration
2. Cerebrovascular or coronary artery disease
3. Acute liver disease
4. 4.benign or malignant liver tumours
5. Severe hypertension/ (BP>180/110 mm Hg)
6. Hypertension with vascular disease
7. Focal migraine.
8. severe cirrhosis
Other Conditions )category 2(

- Women with mild to moderate hypertension,


diabetes (without vascular complications),
hyperlipidaemias, or mild (compensated)
cirrhosis can generally use POIs.
- Careful screening and appropriate
monitoring will allow the benefits of using
POIs to outweigh any potential risks.
COMBINED
INJECTABLE
CONTRACEPTIVES
Mode of Action
Combined injectable contraceptives (CICs)
exert their contraceptive effect mainly by
suppressing ovulation.
In addition, thickening of the cervical
mucus (mainly due to the progestagen)
presents an obstacle to sperm penetration.
The receptivity of endometrium to the
blastocyst is also reduced.
Efficacy
In clinical trials, Cyclofem
/Cycloprovera and
Mesigyna/Norigynon have both
proved highly effective
contraceptives
With 12-month failure rates of 0.2%
or less for Cyclofem and 0.4% for
Mesigyna.
Beneficial Effects
A single injection of a CIC can
provide highly effective protection
against pregnancy for one month.
Delivery is simple and independent
of coitus, and in general CICs are
associated with better cycle control
than POIs.
Side-Effects
In clinical trials, side-effects of CICs
included irregular bleeding,
amenorrhoea, heavy bleeding,
prolonged bleeding, headaches,
dizziness, and body weight
changes.
However, these side-effects are much
less common than with the use of
POIs.
Return of Fertility
The return of fertility following CIC
use is noticeably shorter than that
observed for POIs.
More than 50% of women become
pregnant within six months of
discontinuing CICs and 80% within
one year.
Eligibility Criteria
Until sufficient clinical data become
available, the eligibility criteria for
the use of combined injectable
contraceptives are based on data
from combined oral
contraceptives
Adolescents
Injectable contraceptives have
important advantages in
adolescents; however, in those under
16 years of age there are concerns
regarding the hypo-oestrogenic
effects of POIs, which may affect the
post-menarche increase of bone
mineral density.
Women Over 35
POIs and CICs can be used by most
healthy women over 35.
Any increase in risk of
cardiovascular disease will be
minimal for these women if they do
not smoke and have no other risk
factors, such as hypertension or
diabetes.
Postpartum
)in Breast feeding Women(
If a woman wishes to start injectable
contraception during breastfeeding a POI
should be recommended.
DMPA and NET-EN have no apparent
negative influence on milk production or the
duration of lactation; and infants whose
mothers have received DMPA while
breastfeeding seem to develop normally, both
physically and mentally.
Postpartum
)in Breast feeding Women(
The question of possible
consequences of the transfer of
the injectable steroid to the
breastfed infant has yet to be
resolved.
The amounts of steroid transmitted in
the milk and absorbed by the infant
are known to be small.
Postpartum
)in Breast feeding Women(
Short-term follow-up studies of children
breastfed by mothers using progestagen-
only contraceptives have given reassuring
results, but longer-term studies are yet to
be evaluated.
It is recommended that breastfeeding
women should not start POIs before
the sixth week postpartum.
Postpartum
)in Breastfeeding Women(
There are no data on the effects of CIC
formulations on the quantity and
quality of breast milk or the duration of
lactation.
Until such data become available, CICs
should generally be withheld until six
months after delivery or until the infant
is weaned, whichever is the earlier
Postpartum
)in Non-Breast feeding Women(
To avoid increasing the risk of
thromboembolic complications in the
postpartum period, CICs should not be
used during the first three weeks after
delivery.
After 21 days, blood coagulation and
fibrinolysis are essentially back to normal.
POIs can be started at any time after
delivery.
Drug Interaction
Drugs that induce liver enzymes may
lessen the efficacy of hormonal
contraceptives.
Such drugs which are commonly used in
long-term treatments include the
antibiotics rifampicin and griseofulvin
and the anticonvulsants phenytoin,
carbamazepine, and barbiturates.
Prevention of STD/HIV Transmission
Strict aseptic techniques should be
maintained when giving the injections to avoid
the risk of transmitting any infection including
HIV.
Injectable contraceptives do not protect
against STD/HIV infection.
Therefore, when there is a risk of sexual
transmission of infection, condoms should
always be used in addition to injectable
contraceptives.
Elective Surgery
It is advisable to stop using CICs about four
weeks before elective surgery that will involve
prolonged immobilisation, and to restart them
two weeks after the woman has returned to
mobility.
Alternative effective contraception, including
POIs, should be advised during this time.
In emergency procedures, the surgeon may
consider prophylactic anticoagulant
measures
Sickle Cell Disease
Either POIs or CICs can be used
by women with sickle cell disease
but POIs are a more suitable
choice.
In addition to their contraceptive
effect, there is some evidence of
benefit on the disease itself.
Counselling
Clients considering the use of injectable
contraception should be clearly informed about
the advantages and disadvantages of the
agents, their side-effects, their cost, and the
alternative contraceptive options.
Where once-a-month injectables are available,
clients should be told about the differences
between these injectables and POIs.
Women who desire a rapid return to fertility
on discontinuation of their contraceptive should
be advised to use CICs where available or
another method.
some misconceptions
about injectables
Do injectable contraceptives
cause infertility ?

No.
Although a woman's return to fertility
can be delayed after injectables are
discontinued, injectables do not
damage fertility.
Do injectable contraceptives
increase cancer risks ?

No.
Overall increase in cancer risk has
not been demonstrated in long-
term, multicountry studies of
injectable users.
When amenorrhea occurs, does
menstrual blood build up in the
? body, leading to disease

No.
Amenorrhea is not a health
risk.
It does not cause blood to build
up in the body.
Can injectable contraceptives
transmit disease ?
No.
Injectable contraceptives are sterile
preparations that are free from
disease- causing agents.
Contaminated needles and syringes
used to administer injectables can
transmit disease, however.
special injection
techniques
Injectable contraceptives are
administered using deep
intramuscular injection
techniques.
The injection site should not
be massaged afterwards,
since this may accelerate
absorption of the drug.
Because DMPA is an aqueous
suspension, a DMPA vial must be
shaken vigorously before it is
loaded into the syringe, to
resuspend any active ingredient in
the bottom of the vial.
The syringe should then be checked
to ensure that it contains the correct
dosage.
NET-EN is an oil-based solution
that needs special care to ensure
that all the solution is both loaded
and injected without leakage.
Warming the vial to body
temperature makes it easier to
draw into the syringe.
Since Mesigyna is an oil-based
solution similar to NET-EN, the
same attention to leakage applies.
When can the initial
?injection be given
Progestogen -Only Injectables

DMPA and NET-EN :


During the first 7 days of the menstrual
cycle.
Injectables will be immediately effective.
Immediately after abortion.
At other times in a menstrual cycle as long
as the possibility of pregnancy is ruled out.
At 6 weeks postpartum.
Combined Injectables
Mesigyna
During the first 5 days of the menstrual
cycle.
Injectables will be immediately
effective.
Immediately after abortion.
At other times in a menstrual cycle as
long as the possibility of pregnancy is
ruled out.
At 6 months postpartum.
Margin for
the follow-up
re-injection
Progestogen-Only Injectables
DMPA and NET-EN:
up to 2 weeks )14 days( early or
late

Combined Injectables
Mesigyna:
Up to 3 days early or late
Breast feeding
Progestogen-Only Injectables
DMPA and NET-EN:
Suitable for women who are breastfeeding at
6 weeks postpartum.

Combined Injectables
Mesigyna:
Not suitable for women who are fully breast
feeding until 6 months postpartum.

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