Male And Female Sexual Dysfunction
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.
The percentage of patients reporting symptoms of sexual dysfunction in the Studies 1 and 2 (nonelderly patients with MDD), 4, 5, 6, 7, 8, 9, 10, and 11 are presented in Table 5:
Table 5: Adverse Reactions Related To Sexual Dysfunction In Patients Treated With PAXIL CR in Pooled 10-12 Week Studies of MDD, PD, SAD, and PMDD Studies 1 and 2 % Studies 4, 5, and 6 % Study 7 % Studies 8, 9, and 11 (Continuous Dosing) % Study 10 (Luteal Phase Dosing) % PAXIL CR Placebo PAXIL CR Placebo PAXI L CR Placebo PAXIL CR Placebo PAXI L CR Placebo n (males) 78 78 162 194 88 97 NA NA NA NA Decreased Libido 10 5 9 6 13 1 NA NA NA NA Abnormal ejaculation 26 1 27 3 15 1 NA NA NA NA Impotence 5 3 10 1% 9 0 NA NA NA NA n (females) 134 133 282 251 98 87 681 349 246 120 Decreased Libido 4 2 8 2 4 1 12 5 9 6 Orgasmic Disturbance 10
Serrapress treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.
Serious allergic reaction
In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Serrapress.
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as Serrapress during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, there are also risks when depression is not treated in children and teenagers. Talk to your child's doctor about these risks and whether your child should take an antidepressant, Children younger than 18 years of age should not normally take Serrapress, but in some cases, a doctor may decide that Serrapress is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take Serrapress or other antidepressants to treat depression or other mental illness even if you are an adult over 24 years of age. You may also experience changes in your mental health if you are a woman taking a low dose of Serrapress to treat hot flashes and you have never had depression or another mental illness. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking Serrapress, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with Serrapress. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.
No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Serrapress has not been properly tested with recreational drugs. Talk to your doctor if you think you might use any recreational drugs while taking Serrapress.
Serrapress side effects
Get emergency medical help if you have signs of an allergic reaction to Serrapress (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
unusual bone pain or tenderness, swelling or bruising;
changes in weight or appetite;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or
low levels of sodium in the body - headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.
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.
Common Serrapress side effects may include:
weakness, drowsiness, dizziness, tiredness;
sweating, anxiety, shaking;
loss of appetite, nausea, vomiting, diarrhea, constipation;
dry mouth, yawning;
decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
8. Cautions with other medicines
Some medicines and Serrapress can interfere with each other and increase the chances of you having side effects.
Tell your doctor if you're taking these medicines before you start Serrapress:
- any medicines that affect your heartbeat - as Serrapress can speed up or change your heartbeat
- any other medicines for depression - some rarely used antidepressants can interact with Serrapress to cause very high blood pressure even when they have been stopped for a few weeks
- any medicines for schizophrenia - some rarely used medicines for schizophrenia can interact with Serrapress to cause heart problems
Drug Interaction Studies
There are clinically significant, known drug interactions between Serrapress and other drugs .
Figure 1: Impact of Serrapress on the Pharmacokinetics of Co-Administered Drugs (log scale)
Figure 2: Impact of Co-Administered Drugs on the Pharmacokinetics of Serrapress
Mixing Serrapress with herbal remedies and supplements
Do not take St John's wort, the herbal remedy for depression, while you are being treated with Serrapress as this will increase your risk of side effects.
What if I forget to take it?
If you occasionally forget to take a dose of Serrapress, don't worry. If you remember before bed, take your Serrapress straight away. If you remember during the night, or the next day, leave out the dose completely. Never take 2 doses at the same time to make up for a forgotten one.
If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Serrapress can be fatal.
Serrapress and breastfeeding
If your doctor or health visitor says your baby is healthy, Serrapress can be used during breastfeeding. It has been used by many breastfeeding mothers without any problems.
Serrapress passes into breast milk in very small amounts, and has been linked with side effects in very few breastfed babies.
It is important to continue taking Serrapress to keep you well. Breastfeeding will also benefit both you and your baby.
If you notice that your baby isn't feeding as well as usual, or seems unusually sleepy, or if you have any other concerns about your baby, then talk to your health visitor or doctor as soon as possible.